222. Primary nephrotic syndrome Clinical trials / Disease details


Clinical trials : 285 Drugs : 285 - (DrugBank : 108) / Drug target genes : 62 - Drug target pathways : 191

  
82 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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Status
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agemin
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Inclusion_
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PhaseCountries
1NCT05267262
(ClinicalTrials.gov)
March 15, 202223/2/2022Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental GlomerulosclerosisA Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGCAlport Syndrome;Focal Segmental GlomerulosclerosisDrug: R3R01River 3 Renal Corp.IQVIA BiotechNot yet recruiting12 YearsN/AAll50Phase 2NULL
2EUCTR2021-000621-27-IT
(EUCTR)
11/01/202212/10/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: [RE-021]
INN or Proposed INN: Sparsentan
TRAVERE THERAPEUTICS, INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden
3NCT04983888
(ClinicalTrials.gov)
November 17, 202121/7/2021Obinutuzumab in Primary FSGSA Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose CorticosteroidsPrimary Focal Segmental GlomerulosclerosisDrug: ObinutuzumabMayo ClinicGenentech, Inc.Recruiting18 YearsN/AAll12Phase 2United States
4NCT05162066
(ClinicalTrials.gov)
October 29, 202126/11/2021BCX9930 for the Treatment of C3G, IgAN, and PMN (RENEW)An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With C3G, IgAN, or PMNComplement 3 Glomerulopathy;Immunoglobulin A Nephropathy;Membranous NephropathyDrug: BCX9930BioCryst PharmaceuticalsNULLRecruiting18 YearsN/AAll42Phase 2Italy;Spain
5EUCTR2020-005855-19-ES
(EUCTR)
11/10/202105/08/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy
6EUCTR2021-000621-27-ES
(EUCTR)
08/10/202127/07/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States;Poland
7EUCTR2020-005855-19-IT
(EUCTR)
01/10/202122/10/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BIOCRYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy
8NCT05003986
(ClinicalTrials.gov)
August 12, 202129/7/2021Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular DiseasesA Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular DiseasesFocal Segmental Glomerulosclerosis;Minimal Change Disease;Immunoglobulin A Nephropathy;Immunoglobulin A-Associated Vasculitis;Alport SyndromeDrug: SparsentanTravere Therapeutics, Inc.NULLRecruiting1 Year17 YearsAll57Phase 2United States;Poland;Spain
9ChiCTR2100048382
2021-07-012021-07-06Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical TrialEfficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial Idiopathic membranous nephropathyExperimental group:On the basis of ACEI/ARB, tripterygium wilfordii polyglycoside tablets were added;Control group:The original dose of ACEI/ARB was used for treatment;Department of Nephrology, Sichuan Provincial People's HospitalNULLRecruiting1865BothExperimental group:18;Control group:18;N/AChina
10NCT04629248
(ClinicalTrials.gov)
June 25, 202127/10/2020A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous NephropathyA Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous NephropathyPrimary Membranous NephropathyDrug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: DiphenhydramineHoffmann-La RocheNULLRecruiting18 Years75 YearsAll140Phase 3United States;Argentina;Brazil;China;France;Israel;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine;Peru
11EUCTR2020-004176-18-ES
(EUCTR)
21/06/202109/02/2021A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - The AFFINITY Study Proteinuric glomerular diseases, including:Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
Chinook Therapeutics U.S., Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Spain;Australia;United Kingdom;Korea, Republic of
12EUCTR2020-002637-15-FR
(EUCTR)
09/06/202102/02/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
13EUCTR2020-004176-18-IT
(EUCTR)
08/06/202108/06/2021A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) - AFFINITY Study Proteinuric glomerular diseases, including: Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: atrasentan
Product Code: [atrasentan]
INN or Proposed INN: atrasentan
Other descriptive name: ATRASENTAN
CHINOOK THERAPEUTICS, U.S., IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Spain;Australia;United Kingdom;Italy;Korea, Republic of
14EUCTR2020-003233-38-PL
(EUCTR)
13/04/202124/02/2021A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous NephropathyA PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY Primary Membranous Nephropathy (pMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Obinutuzumab
Product Code: RO5072759
INN or Proposed INN: OBINUTUZUMAB
Other descriptive name: OBINUTUZUMAB/ GA101
Product Name: Tacrolimus
Product Code: RO0485337
INN or Proposed INN: Tacrolimus
Product Name: Tacrolimus
Product Code: RO0485337
INN or Proposed INN: Tacrolimus
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Peru;China
15EUCTR2020-002637-15-IT
(EUCTR)
09/04/202104/06/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: [APL-2]
INN or Proposed INN: Pegcetacoplan
Trade Name: Prevenar 13 suspension for injection
Product Name: Prevenar 13 suspension for injection
Product Code: [na]
INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg
Trade Name: Pneumococcal polysaccharide vaccine
Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial
Product Code: [na]
INN or Proposed INN: Pneumococcal Polysaccharide Vaccine
Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States
16EUCTR2020-003233-38-IT
(EUCTR)
06/04/202104/06/2021A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous NephropathyA PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY - A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropa Primary Membranous Nephropathy (pMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Gazyvaro
Product Name: Obinutuzumab
Product Code: [RO5072759]
INN or Proposed INN: OBINUTUZUMAB
Other descriptive name: OBINUTUZUMAB/ GA101
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Adoport
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
Trade Name: Adoport
Product Name: Tacrolimus
Product Code: [RO0485337]
INN or Proposed INN: TACROLIMUS
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Brazil;Poland;Peru;China
17EUCTR2020-002637-15-NL
(EUCTR)
29/03/202104/01/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
18NCT04572854
(ClinicalTrials.gov)
February 23, 202129/9/2020Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGNC3G;IC-MPGN;Renal Transplant;Complement 3 Glomerulopathy;Complement 3 Glomerulopathy (C3G);Dense Deposit Disease;Membranoproliferative Glomerulonephritis;Membranoproliferative Glomerulonephritis (MPGN);Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)Drug: PegcetacoplanApellis Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll12Phase 2United States
19NCT04573920
(ClinicalTrials.gov)
February 1, 202128/9/2020Atrasentan in Patients With Proteinuric Glomerular DiseasesA Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular DiseasesIgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A NephropathyDrug: AtrasentanChinook Therapeutics U.S., Inc.NULLRecruiting18 YearsN/AAll80Phase 2United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom
20NCT04733040
(ClinicalTrials.gov)
January 20, 202118/1/2021Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) (NewPLACE)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)Glomerulonephritis;Membranous Nephropathy;antiPLA2R PositiveDrug: MOR202MorphoSys AGNULLRecruiting18 Years80 YearsAll22Phase 2Georgia;Germany;Greece;Korea, Republic of;Russian Federation;Taiwan;United Kingdom
21EUCTR2019-000780-24-PL
(EUCTR)
07/01/202114/09/2020Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Poland;Australia;Netherlands;Italy;Korea, Republic of
22EUCTR2020-002637-15-GB
(EUCTR)
22/12/202023/10/2020Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Switzerland;Italy;United Kingdom
23EUCTR2020-002985-15-DE
(EUCTR)
21/12/202031/08/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
24EUCTR2019-003607-35-CZ
(EUCTR)
26/11/202026/11/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan
25EUCTR2019-003607-35-SK
(EUCTR)
12/11/202009/10/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
26EUCTR2019-003607-35-IT
(EUCTR)
03/11/202002/08/2021A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) - - Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: [PF-06730512]
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
PFIZER INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Czechia;Slovakia;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan
27EUCTR2019-003607-35-DE
(EUCTR)
26/10/202002/10/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
28EUCTR2019-003607-35-PL
(EUCTR)
23/10/202020/10/2020A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Product Name: PF-06730512
Product Code: PF-06730512
INN or Proposed INN: PF-06730512
Other descriptive name: PF-06730512
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
29EUCTR2020-002985-15-GR
(EUCTR)
22/10/202011/09/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
30EUCTR2020-002985-15-GB
(EUCTR)
12/10/202025/08/2020Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE Anti-PLA2R antibody positive membranous nephropathy (aMN)
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MOR202
INN or Proposed INN: not yet assigned
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22Phase 2Taiwan;Greece;Australia;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
31NCT04183101
(ClinicalTrials.gov)
October 1, 202014/11/2019Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 GlomerulopathyPhase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 GlomerulopathyC3 Glomerulopathy;Membranoproliferative Glomerulonephritis;Complement Abnormality;Dense Deposit Disease;C3 GlomerulonephritisDrug: Aliskiren;Drug: EnalaprilRegion SkaneNULLRecruiting6 YearsN/AAll30Phase 2Sweden
32EUCTR2019-001212-29-DK
(EUCTR)
26/08/202009/06/2020Causes and prevention of thrombosis developed due to the kidney disease nephrotic syndromeCauses and Prevention of Thromboembolic Disease in Nephrotic Syndrome Nephrotic syndrome is defined as severe proteinuria (> 0.5 g / day), edema and hypoalbuminemia. It is conditioned by a defect in the kidney's glomerular filtration barrier, resulting in the loss of a large number of plasma proteins including coagulation factors and consequently a increased risk of thromboembolic complications. The most frequent cause of nephrotic syndrome is the renal disease membranous nephropathy, which is associated with the greatest risk of thromboembolic complications.
MedDRA version: 21.1;Level: LLT;Classification code 10029167;Term: Nephrotic syndrome with lesion of membranous glomerulonephritis;System Organ Class: 100000004857
MedDRA version: 20.0;Classification code 10029165;Term: Nephrotic syndrome in diseases classified elsewhere;System Organ Class: 100000004857;Therapeutic area: Not possible to specify
Trade Name: Fragmin
INN or Proposed INN: Dalteparin
Other descriptive name: Dalteparin
Trade Name: Eliquis
INN or Proposed INN: Apixaban
Other descriptive name: Apixaban
Aarhus University Hospital, Henrik BirnNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 1;Phase 2Denmark
33EUCTR2020-000185-42-FR
(EUCTR)
12/06/202026/05/2020Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis.A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. APOL1-mediated Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX-147
Product Code: VX-147
INN or Proposed INN: VX147
Other descriptive name: VX-147
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2United States;France;United Kingdom
34NCT04340362
(ClinicalTrials.gov)
June 8, 20207/4/2020Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental GlomerulosclerosisA Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental GlomerulosclerosisGlomerulosclerosis, Focal SegmentalDrug: VX-147Vertex Pharmaceuticals IncorporatedNULLCompleted18 Years65 YearsAll16Phase 2United States;France;Puerto Rico;United Kingdom
35EUCTR2020-000185-42-GB
(EUCTR)
01/06/202023/03/2020Phase 2a Study of VX 147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis.A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis. APOL1-mediated Focal segmental glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: VX-147
Product Code: VX-147
INN or Proposed INN: VX147
Other descriptive name: VX-147
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2France;United States;United Kingdom
36EUCTR2019-001734-34-NL
(EUCTR)
07/04/202022/08/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, open-label, two-arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 500 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 2United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Netherlands;Germany;China
37NCT04065438
(ClinicalTrials.gov)
January 1, 202020/8/2019Post Approval Study for Treatment of Drug-resistant Adult Primary FSGS Using the LIPOSORBER® LA-15 SystemTreatment of Drug-resistant Adult Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 SystemFocal Segmental GlomerulosclerosisDevice: LIPOSORBER® LA-15Kaneka Medical America LLCNULLRecruiting22 Years75 YearsAll35N/AUnited States
38NCT04154787
(ClinicalTrials.gov)
November 23, 20198/10/2019Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous NephropathyA Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous NephropathyGlomerulonephritis, MembranousDrug: LNP023;Drug: RituximabNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll52Phase 2United States;Argentina;China;Czechia;France;Germany;India;Netherlands;Singapore;Spain;Taiwan;United Kingdom
39EUCTR2019-001734-34-ES
(EUCTR)
12/11/201904/09/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
40EUCTR2019-001734-34-DE
(EUCTR)
30/10/201912/09/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, open-label, two arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 500 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
52Phase 2United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Germany;Netherlands;China
41EUCTR2019-000780-24-ES
(EUCTR)
25/10/201926/07/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Netherlands
42EUCTR2019-001734-34-FR
(EUCTR)
23/10/201913/09/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
43NCT04145440
(ClinicalTrials.gov)
October 15, 201918/10/2019Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)Glomerulonephritis, Membranous;antiPLA2R PositiveDrug: MOR202MorphoSys AGNULLActive, not recruiting18 Years80 YearsAll30Phase 1/Phase 2United States;Australia;Belgium;France;Italy;Korea, Republic of;Netherlands;Poland;Spain
44EUCTR2017-003022-32-PL
(EUCTR)
12/10/201920/08/2019An open, dose escalation study in patients with Primary Focal Segmental Glomerulosclerosis (FSGS - a type of glomerular disease causes scarring in the kidney) and Nephrotic Syndrom (collection of symptoms due to kidney damage)An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome Primary Focal Segmental Glomerulosclerosis (FSGS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CCX140-B
INN or Proposed INN: not available yet
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
13Phase 2United Kingdom;Poland;Canada;France;United States
45EUCTR2019-000780-24-IT
(EUCTR)
08/10/201922/01/2020Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Spain;Netherlands;Italy
46EUCTR2019-000780-24-NL
(EUCTR)
24/09/201903/07/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1;Phase 2France;United States;European Union;Poland;Spain;Australia;Netherlands;Italy;Korea, Republic of
47EUCTR2019-001734-34-GB
(EUCTR)
23/09/201907/08/2019Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy. Idiopathic Membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: MabThera 500 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
48EUCTR2019-000780-24-FR
(EUCTR)
23/09/201915/10/2019Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyA Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE Primary (anti-PLA2R antibody positive) Membranous Nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MOR202
Product Code: MOR202
INN or Proposed INN: No INN assigned yet
Other descriptive name: MOR03087
MorphoSys AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;European Union;Spain;Netherlands
49EUCTR2017-002674-39-NL
(EUCTR)
30/01/201918/07/2018A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Australia;Netherlands;Italy
50NCT03448692
(ClinicalTrials.gov)
October 15, 201822/2/2018A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)Focal Segmental Glomerulosclerosis (FSGS)Drug: PF-06730512PfizerNULLRecruiting18 YearsN/AAll44Phase 2United States;Canada;Czechia;France;Germany;Italy;Japan;Mexico;Poland;Slovakia;Spain;United Kingdom
51NCT03703908
(ClinicalTrials.gov)
October 1, 201824/7/2018A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic SyndromeAn Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic SyndromeFocal Segmental GlomerulosclerosisDrug: CCX140-BChemoCentryxNULLRecruiting18 YearsN/AAll13Phase 2United States
52EUCTR2017-002674-39-IT
(EUCTR)
03/08/201808/06/2021A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (ICMPGN)An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 - N/A C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: PT;Classification code 10018364;Term: Glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ACH-0144471 compresse
Product Code: ACH-0144471
INN or Proposed INN: ACH-0144471
Product Name: ACH-0144471 compresse
Product Code: ACH-0144471
INN or Proposed INN: ACH-0144471
Product Name: ACH0144471 compresse
Product Code: ACH0144471
INN or Proposed INN: ACH-0144471
Trade Name: TETRACT-HIB - 1 SIRINGA PRECARICATA 0.5 ML
Product Name: ACT-HIB
Product Code: [ACT-HIB]
Product Name: Bexsero
Product Code: [Bexsero]
Product Name: Menveo
Product Code: [Menveo]
Trade Name: PREVENAR 13 - 0.5 ML SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - FLACONCINO MONODOSE (0,5 ML VETRO TIPO I) - 1 FLACONCINO MONODOSE
Product Name: Prevenar 13
Product Code:
ACHILLION PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Australia;Netherlands;Italy
53EUCTR2017-002674-39-BE
(EUCTR)
31/07/201816/05/2018A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;Belgium;Australia;Netherlands;Italy
54EUCTR2016-003525-42-NL
(EUCTR)
26/06/201809/01/2018A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Australia;Netherlands
55NCT03598036
(ClinicalTrials.gov)
June 21, 201814/6/2018Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental GlomerulosclerosisAn Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisDrug: VoclosporinAurinia Pharmaceuticals Inc.NULLTerminated18 Years75 YearsAll5Phase 2United States;Dominican Republic
56NCT03459443
(ClinicalTrials.gov)
June 20, 201826/2/2018A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471An Open-Label Phase 2 Proof-of-Concept Study in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated With ACH-0144471C3 Glomerulonephritis;C3 Glomerulopathy;Immune Complex Membranoproliferative Glomerulonephritis;IC-MPGN;Dense Deposit DiseaseDrug: DanicopanAlexion PharmaceuticalsNULLCompleted12 YearsN/AAll22Phase 2United States;Australia;Belgium;Italy;Netherlands
57NCT03422510
(ClinicalTrials.gov)
April 15, 201830/1/2018FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS)Primary Focal Segmental GlomerulosclerosisDrug: CXA-10Complexa, Inc.Kidney Research Network, formerly NephCure Accelerating Cures Institute;Medpace, Inc.;MicroConstants;Arkana Labs;NephCure Kidney InternationalCompleted13 YearsN/AAll33Phase 2United States
58NCT03285711
(ClinicalTrials.gov)
October 6, 201714/9/2017Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN)Lupus Membranous NephropathyDrug: Filgotinib;Drug: Lanraplenib;Drug: Filgotinib placebo;Drug: Lanraplenib placeboGilead SciencesNULLCompleted18 Years75 YearsAll9Phase 2United States
59NCT03095118
(ClinicalTrials.gov)
September 7, 201720/3/2017Daratumumab in Treatment of PGNMID and C3 GNSingle-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal GammopathyMembranoproliferative GlomerulonephritisDrug: DaratumumabFernando FervenzaNULLActive, not recruiting18 YearsN/AAll10Phase 2United States
60NCT03124368
(ClinicalTrials.gov)
August 9, 201712/4/2017A Proof-of-Mechanism Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With C3G or IC-MPGNA Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)C3 Glomerulonephritis;Dense Deposit Disease;Membranoproliferative Glomerulonephritis, Type II;C3 Glomerulopathy;Immune Complex Mediated Membranoproliferative GlomerulonephritisDrug: ACH-0144471Alexion PharmaceuticalsNULLCompleted16 Years65 YearsAll6Phase 2Australia;Belgium;Netherlands
61NCT02921789
(ClinicalTrials.gov)
May 22, 201730/9/2016Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant RecipientsA Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant RecipientsKidney Transplantation;Focal Segmental Glomerulosclerosis (FSGS)Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: PrednisoneAstellas Pharma Global Development, Inc.Kyowa Kirin Co., Ltd.Completed18 YearsN/AAll71Phase 2United States;Canada
62EUCTR2013-000226-55-NL
(EUCTR)
04/03/201524/06/2014SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHYEuropean Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN Primary membranous nephropathy
MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: Tacrolimus
Product Name: TACROLIMUS
INN or Proposed INN: TACROLIMUS
Other descriptive name: TACROLIMUS
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE ACETATE
Trade Name: cyclophosphamide
Product Name: cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Fundacion Renal Iñigo Alvarez ToledoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
175Spain;Netherlands
63NCT02235857
(ClinicalTrials.gov)
March 20156/9/2014Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in ChildrenTreatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 SystemFocal Segmental GlomerulosclerosisDevice: LIPOSORBER® LA-15 SystemKaneka Medical America LLCNULLRecruitingN/A21 YearsAll35N/AUnited States
64NCT01955187
(ClinicalTrials.gov)
January 201419/9/2013Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous NephropathyEuropean Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study)MEMBRANOUS NEPHROPATHYDrug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDEHospital Universitario 12 de OctubreInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, AachenCompleted18 YearsN/AAll86Phase 3Spain
65NCT01791686
(ClinicalTrials.gov)
January 201329/1/2013Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit DiseaseA Pilot, Open-label, Multicenter Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit DiseaseDense Deposit Disease;Membranoproliferative Glomerulonephritis Type II;C3 GlomerulonephritisDrug: CDX-1135Celldex TherapeuticsNULLTerminated4 YearsN/ABoth1Phase 1United States
66NCT01763580
(ClinicalTrials.gov)
July 16, 20126/12/2012A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic SyndromeOpen-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)MCNS;Minimal Change Nephrotic Syndrome (MCNS)Drug: Tacrolimus;Drug: PrednisoloneAstellas Pharma Korea, Inc.NULLCompleted16 Years78 YearsAll144Phase 4Korea, Republic of
67NCT01508468
(ClinicalTrials.gov)
January 17, 20129/12/2011Evaluate Rituximab Treatment for Idiopathic Membranous NephropathyProspective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin);Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll80Phase 3France
68NCT01180036
(ClinicalTrials.gov)
November 201110/8/2010MEmbranous Nephropathy Trial Of RituximabA Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: Rituximab;Drug: CyclosporineMayo ClinicColumbia University;University of British Columbia;Ohio State University;Stanford University;University of Washington;University of Michigan;University of Alabama at Birmingham;Case Western Reserve University;The Cleveland Clinic;University of Kansas Medical Center;University of Manchester;University Health Network, Toronto;University of Toronto;CHU de Quebec-Universite Laval;Washington University School of Medicine;Florida International University;University of Mississippi Medical Center;NYU Langone Health;Medical College of Wisconsin;University of Arizona;Sunnybrook Health Sciences Centre;Applied Health Research Centre;Fulk Family FoundationCompleted18 Years80 YearsAll130Phase 2/Phase 3United States;Canada
69EUCTR2007-005410-39-ES
(EUCTR)
11/06/200808/04/2008Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTACEstudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC La nefropatía membranosa idiopática (NMI) es una enfermedad caracterizada histopatológicamente por un engrosamiento uniforme de la pared de los capilares glomerulares, debido al depósito de complejos inmunes a lo largo del espacio subepitelial, en ausencia de inflamación o cambios proliferativos en el resto del glomérulo. El origen exacto de este trastorno se desconoce sin embargo se sabe que la NMI es una causa frecuente de síndrome nefrótico (SN) del adulto.
MedDRA version: 9.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy
Trade Name: Advagraf 0,5mg
INN or Proposed INN: tacrolimus
Trade Name: Genoxal
INN or Proposed INN: ciclofosfamida
Trade Name: Dacortín 2,5mg
INN or Proposed INN: prednisona
Trade Name: Advagraf 1mg
INN or Proposed INN: tacrolimus
Trade Name: Advagraf 5mg
INN or Proposed INN: tacrolimus
Trade Name: Dacortín 5mg
INN or Proposed INN: prednisona
Trade Name: Dacortín 30mg
INN or Proposed INN: prednisona
Grupo Catalán de Estudio de enfermedades glomerulares. Sociedad Catalana de nefrología.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Spain
70NCT00782561
(ClinicalTrials.gov)
April 200827/10/2008Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisDrug: FG-3019FibroGenNULLTerminated12 Years64 YearsAll2Phase 1United States
71NCT00464321
(ClinicalTrials.gov)
May 200720/4/2007Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGSA Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental GlomerulosclerosisBiological: GC1008Genzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth16Phase 1United States;Germany;Italy;United Kingdom
72NCT00983034
(ClinicalTrials.gov)
March 200621/9/2009The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous NephropathyProspective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous NephropathyNephrotic Syndrome;Glomerulonephritis;Membranous NephropathyDrug: lansoprazole, amoxicillin, clarithromycinIstanbul UniversityNULLCompleted18 Years70 YearsBoth70N/ATurkey
73JPRN-C000000369
2004/04/0127/03/2006Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndromeCyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks
CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks
Project team for treatment of refractory nephrotic syndromeThe Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, JapanComplete: follow-up complete16years-old75years-oldMale and Female300Not selectedJapan
74JPRN-C000000368
2004/04/0127/03/2006Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome membranous nephropathy with primary steroid resistant nephrotic syndromemizoribine once a day per os administration (150mg) after breakfast for 2years.



mizoribine 3 times a day per os administration (50mg each) after meals for 2years.
Project team for treatment of refractory nephrotic syndromeThe Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, JapanComplete: follow-up complete16years-old75years-oldMale and Female100Not selectedJapan
75NCT00404833
(ClinicalTrials.gov)
January 200327/11/2006Mycophenolate Mofetil in Membranous Nephropathy and Focal SegmentalA Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS)Glomerulonephritis, Membranous;Glomerulosclerosis, FocalDrug: prednisolone and mycophenolate mofetil;Drug: prednisolone and chlorambucilHospital Authority, Hong KongThe University of Hong KongCompleted18 Years65 YearsBoth16Phase 3China
76NCT00135967
(ClinicalTrials.gov)
May 200225/8/2005Mycophenolate Mofetil in Membranous NephropathyTreatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot StudyGlomerulonephritis, MembranousDrug: mycophenolate mofetil orally 1000 mg twice a day (BID);Drug: prednisone 0,5 mg/kg orally on alternate days;Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9Radboud UniversityHoffmann-La RocheCompleted18 Years75 YearsBoth30Phase 2/Phase 3Netherlands
77NCT00135954
(ClinicalTrials.gov)
July 199725/8/2005Treatment of Patients With Idiopathic Membranous NephropathyTreatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive TherapyGlomerulonephritis, MembranousDrug: Cyclophosphamide and steroidsRadboud UniversityNULLCompleted18 Years75 YearsBoth29Phase 3Netherlands
78EUCTR2016-003525-42-BE
(EUCTR)
30/10/2017A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Product Code: ACH-0144471
INN or Proposed INN: Not available
Other descriptive name: ACH-0144471
Achillion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Australia;Netherlands
79EUCTR2021-000621-27-DE
(EUCTR)
08/09/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLNAFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden
80EUCTR2015-001039-18-Outside-EU/EEA
(EUCTR)
03/07/2015Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndromeOpen-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Prograf
INN or Proposed INN: TACROLIMUS
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Trade Name: Solondo
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Astellas Pharma Korea, Inc.NULLNAFemale: yes
Male: yes
152Korea, Republic of
81EUCTR2021-000621-27-NL
(EUCTR)
14/12/2021A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLNAFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Germany;Netherlands;United Kingdom;Italy;Sweden
82EUCTR2021-000621-27-PL
(EUCTR)
01/09/2021Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS)
MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858
MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Product Name: Sparsentan
Product Code: RE-021
INN or Proposed INN: Sparsentan
Other descriptive name: SPARSENTAN
Travere Therapeutics, Inc.NULLNAFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden