218. アルポート症候群 Alport syndrome Clinical trials / Disease details


臨床試験数 : 30 薬物数 : 36 - (DrugBank : 15) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 46

  
No.TrialIDDate_
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PhaseCountries
1NCT05655728
(ClinicalTrials.gov)
January 3, 20238/12/2022Treatment With Metformin in Chinese Children With Alport SyndromeEfficacy and Safety of Metformin in Alport Syndrome: A Randomized, Double-blind, Placebo-controlled Study in ChinaAlport Syndrome;MetforminDrug: Metformin;Other: PlaceboPeking University First HospitalNULLNot yet recruiting10 Years18 YearsAll78Phase 4NULL
2NCT05448755
(ClinicalTrials.gov)
November 28, 202229/6/2022A Study of ELX-02 in Patients With Alport SyndromeA Phase 2 Open Label Pilot Study to Evaluate the Safety and Efficacy of Subcutaneously Administered ELX-02 in Patients With Alport Syndrome With Col4A5 and Col4A3/4 Nonsense MutationAlport SyndromeDrug: ELX-02Eloxx Pharmaceuticals, Inc.NULLRecruiting6 Years30 YearsAll8Phase 2Australia;United Kingdom
3NCT05267262
(ClinicalTrials.gov)
June 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.NULLRecruiting12 YearsN/AAll50Phase 2United States;Belgium;France;Germany;Netherlands;United Kingdom
4EUCTR2021-000621-27-NL
(EUCTR)
22/03/202214/12/2021Safety, 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 2France;United States;Spain;Poland;Germany;Netherlands;United Kingdom;Italy;Sweden
5EUCTR2021-000621-27-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
6NCT05133050
(ClinicalTrials.gov)
January 1, 202227/10/2021Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 VariantsSafety and Efficacy of Early Angiotensin-converting Enzyme Inhibition in Patients With Alport Syndrome Carrying Pathogenic Heterozygous COL4A3,COL4A4 or COL4A5 MutationsAlport SyndromeDrug: RamiprilXinhua Hospital, Shanghai Jiao Tong University School of MedicineNULLNot yet recruiting30 Years50 YearsAll510N/AChina
7EUCTR2021-000621-27-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
8NCT04937907
(ClinicalTrials.gov)
September 8, 202117/6/2021Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)Efficacy and Safety of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)Alport Syndrome, X-LinkedDrug: Hydroxychloroquine Sulfate 100 milligram (mg) Tab;Drug: Benazepril hydrochloride 10 milligram (mg) TabShanghai Children's HospitalNULLRecruiting3 Years18 YearsAll50Phase 2China
9NCT05003986
(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;IgA Vasculitis;Alport SyndromeDrug: SparsentanTravere Therapeutics, Inc.NULLRecruiting1 Year17 YearsAll57Phase 2United States;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
10NCT04573920
(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/AAll100Phase 2United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom
11ChiCTR2000036799
2020-10-012020-08-25Construction and clinical transformation of integrated platform for accurate diagnosis and treatment of Alport syndromeConstruction and clinical transformation of integrated platform for accurate diagnosis and treatment of Alport syndrome Alport Syndromeexperimental group:Hydroxychloroquine + Benazepril Hydrochloridec;control group:placebo + benazepril hydrochloride;Shanghai Children's HospitalNULLPending018Bothexperimental group:25;control group:25;N/AChina
12ChiCTR2000036550
2020-09-012020-08-24Enzyme-linked immunosorbent determination of urine IV collagen alpha chain early warning value for Alport syndromeEnzyme-linked immunosorbent determination of urine IV collagen alpha chain early warning value for Alport syndrome Alport syndromeGold Standard:Renal biopsy, skin biopsy and genetic test.;Index test:urine IV collagen a chain test;Children's Hospital of ShanghaiNULLRecruiting018BothTarget condition:60;Difficult condition:70China
13EUCTR2019-004394-10-DE
(EUCTR)
30/06/202009/12/2019Study of lademirsen (SAR339375) in patients with Alport SyndromeA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients with Alport Syndrome - HERA Congenital, hereditary and neonatal diseases
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Lademirsen
Product Code: SAR339375
Other descriptive name: RG-012
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2France;United States;Spain;Australia;Germany;United Kingdom;China
14NCT02855268
(ClinicalTrials.gov)
November 2, 201928/7/2016Study of Lademirsen (SAR339375) in Patients With Alport SyndromeA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients With Alport SyndromeAlport's SyndromeDrug: lademirsen (SAR339375);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 Years55 YearsAll43Phase 2United States;Australia;China;France;Germany;Spain;United Kingdom;Canada
15NCT03749447
(ClinicalTrials.gov)
March 8, 201919/11/2018An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney DiseaseChronic Kidney Diseases;Alport Syndrome;Autosomal Dominant Polycystic KidneyDrug: Bardoxolone methylReata Pharmaceuticals, Inc.NULLRecruiting12 YearsN/AAll480Phase 3United States;Australia;France;Japan;Puerto Rico;Spain
16JPRN-UMIN000032448
2018/05/0101/05/2018A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport SyndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport SyndromeDrug: Bardoxolone Methyl
Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status. Dosing period is up to 2 years.
Drug: Placebo Oral Capsule
Capsule containing an inert placebo is administrated up to 2 years.
Reata Pharmaceuticals, IncNULLComplete: follow-up complete12years-old70years-oldMale and Female180Phase 2/3Japan,North America,Australia,Europe
17EUCTR2016-004395-22-GB
(EUCTR)
28/03/201831/10/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Australia;Germany;United Kingdom
18EUCTR2016-004395-22-ES
(EUCTR)
24/01/201807/11/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2;Phase 3United States;France;Canada;Spain;Australia;Germany;United Kingdom
19NCT03373786
(ClinicalTrials.gov)
December 22, 201722/10/2017A Study of RG-012 in Subjects With Alport SyndromeA Phase 1, Open-Label Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of RG-012 for Injection, Including Its Effect on Renal microRNA-21, in Subjects With Alport SyndromeAlport SyndromeDrug: RG012Genzyme, a Sanofi CompanyNULLCompleted18 Years65 YearsAll4Phase 1United States
20EUCTR2016-004395-22-DE
(EUCTR)
19/12/201725/09/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2;Phase 3United States;France;Canada;Spain;Australia;Germany;United Kingdom
21EUCTR2016-004395-22-FR
(EUCTR)
04/12/201705/12/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3United States;France;Canada;Spain;Australia;Germany;United Kingdom
22NCT03019185
(ClinicalTrials.gov)
March 2, 20176/1/2017A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINALA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport SyndromeAlport SyndromeDrug: Placebo Oral Capsule;Drug: Bardoxolone MethylReata Pharmaceuticals, Inc.NULLCompleted12 Years60 YearsAll187Phase 2/Phase 3United States;Australia;France;Germany;Japan;Puerto Rico;Spain;United Kingdom;Canada
23EUCTR2016-002181-32-GB
(EUCTR)
07/12/201608/09/2016A research study to evaluate the safety and effectiveness of RG-012 as a treatment for patients with Alport syndromeA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Dose Selection, and Preliminary Efficacy of Weekly RG 012 Injections in Patients with Alport Syndrome - A Phase 2 Study to Evaluate Weekly RG012 Injections in Alport Syndrome Alport syndrome is an inherited form of kidney disease caused by mutations in genes coding for the capillary basement membrane collagen IV;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Product Code: RG-012Regulus Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Australia;Germany;United Kingdom
24NCT01485978
(ClinicalTrials.gov)
March 20122/12/2011Efficacy and Safety Study to Delay Renal Failure in Children With Alport SyndromeEarly Prospective Therapy Trial to Delay Renal Failure in Children With Alport SyndromeRenal Insufficiency, ChronicDrug: Ramipril;Drug: placebo to ramiprilInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbHUniversity Medical Center Goettingen;German Federal Ministry of Education and ResearchCompleted24 Months18 YearsAll66Phase 3Germany
25EUCTR2010-024300-10-DE
(EUCTR)
27/02/201212/12/2011Early prospective therapy trial to delay renal failure in children with Alport syndrome. - EARLY PRO-TECT AlportEarly prospective therapy trial to delay renal failure in children with Alport syndrome. - EARLY PRO-TECT Alport Alport's syndrome
MedDRA version: 19.1;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Delix
Product Name: Delix
Other descriptive name: RAMIPRIL
University Medical Center GöttingenNULLNot RecruitingFemale: yes
Male: yes
120Phase 3Germany
26NCT00309257
(ClinicalTrials.gov)
January 200430/3/2006Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport SyndromeEffects of an Intensified Treatment With ACE-inhibitors, Angiotensin II Receptor Antagonists and Statins in Alport SyndromeAlport SyndromeDrug: ACE I, ATA II and Statins;Drug: Benazepril, Valsartan and FluvastatinMario Negri Institute for Pharmacological ResearchNULLCompleted15 Years70 YearsBoth9Phase 2Italy
27NCT02378805
(ClinicalTrials.gov)
July 199526/2/2015European Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport SyndromeEuropean Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome: Current and Novel TherapiesFamilial Benign Hematuria;Alport Syndrome;Hereditary Kidney Disease;Pediatric Kidney Disease;Thin Basement Membrane DiseaseDrug: ACE-inhibitor;Drug: AT1-inhibitor;Drug: HMG-Coenzyme inhibitor (statin);Drug: Spironolactone;Drug: Paricalcitol;Drug: SGLT2 inhibitorUniversity Hospital GoettingenSociety for Pediatric Nephrology (Germany);Deutsche Gesellschaft für Nephrologie;Alport Selbsthilfe e.V.;Association pour l'Information et la Recherche sur les Maladies Rénales Génétiques (AIRG);KfH Foundation Preventive MedicineRecruitingN/AN/AAll500Germany
28EUCTR2021-000621-27-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.NULLNot RecruitingFemale: yes
Male: yes
57Phase 2France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden
29EUCTR2021-000621-27-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
30EUCTR2021-004192-13-BE
(EUCTR)
19/05/2022R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental GlomerulosclerosisA Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis - R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis Alport Syndrome (AS) and Primary Steroid-Resistent FocalSegmental Glomerulosclerosis (FSGS)
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.1;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify
Product Name: R3R01
INN or Proposed INN: not available
Other descriptive name: R3R01
River 3 Renal, CorporationNULLNAFemale: yes
Male: yes
50Phase 2France;United States;Belgium;Germany;Netherlands;United Kingdom