222. 一次性ネフローゼ症候群 Primary nephrotic syndrome Clinical trials / Disease details


臨床試験数 : 285 薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191

  
41 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT05050214
(ClinicalTrials.gov)
March 20229/9/2021Obinutuzumab in Primary MNObinutuzumab for Primary Membranous Nephropathy: a Pilot Study in Patients With Rituximab-resistant or Rituximab-dependent Nephrotic Syndrome and in Patients Intolerant to Rituximab (the ORION Study)Membranous NephropathyDrug: ObinutuzumabMario Negri Institute for Pharmacological ResearchRoche S.p.aNot yet recruiting18 YearsN/AAll20Phase 2Italy
2EUCTR2021-004864-81-IT
(EUCTR)
17/12/202117/09/2021Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION)Proposta di studio per valutare l’efficacia di Obinutuzumab, un anticorpo anti-CD20, in pazienti con nefropatia membranosa intolleranti, resistenti o dipendenti alla terapia con Rituximab (studio ORION) - Obinutuzumab in primary MN PRIMARY MEMBRANOUS NEPHROPATHY
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Trade Name: GAZYVARO - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 1000MG/40ML - 1 FLACONCINO
Product Name: GAZYVARO
Product Code: [L01XC15]
INN or Proposed INN: Obitunuzumab
Trade Name: OMNIPAQUE - 300 MG I/ML SOLUZIONE INIETTABILE FLACONE IN POLIPROPILENE DA 50 ML
Product Name: OMNIPAQUE
Product Code: [Ioexolo]
INN or Proposed INN: ioexolo
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Italy
3NCT04743739
(ClinicalTrials.gov)
April 14, 202130/1/2021Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMNA Multicenter Randomized Controlled Trial of Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of Idiopathic Membranous NephropathyIdiopathic Membranous NephropathyDrug: Rituximab;Drug: cyclosporinePeking Union Medical College HospitalBeijing Tongren Hospital;Chinese Academy of Medical Sciences, Fuwai Hospital;The Luhe Teaching Hospital of the Capital Medical University;The Seventh Affiliated Hospital, Sun Yat-sen University;First Affiliated Hospital of Xinjiang Medical University;Nanyang Nanshi Hospital of Henan University;Shanghai Fosun Pharmaceutical Development Co, Ltd.Recruiting18 Years80 YearsAll126Phase 3China
4NCT04745728
(ClinicalTrials.gov)
April 14, 20214/2/2021Different Immunosuppressive Treatment in iMNDifferent Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective CohortIdiopathic Membranous NephropathyDrug: Prednisone;Drug: Cyclophosphamide;Drug: RituximabPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll200Phase 3China
5ChiCTR2100042674
2021-01-182021-01-26Standard dose Rituximab for membranous nephropathy: a multi-center prospective cohort studyStandard dose Rituximab for membranous nephropathy: a multi-center prospective cohort study syndrome diseaseexperimental group:RTX treatment;Jiangsu Province People's HospitalNULLRecruiting1875Maleexperimental group:65;Phase 4China
6NCT03970577
(ClinicalTrials.gov)
July 29, 202015/4/2019RItuximab From the FIRst Episode of Idiopathic Nephrotic SyndromeRituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled TrialMinimal Change Nephrotic Syndrome (MCNS)Drug: Rituximab;Drug: PrednisoneAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll148Phase 2France
7ChiCTR2000032523
2020-06-012020-05-01Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial.Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial membranous nephropathyexperimental group:rituximab;control group:tacrolimus;Xinqiao HospitalNULLPending1880Bothexperimental group:40;control group:40;Phase 4China
8ChiCTR2000033540
2020-06-012020-06-04Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous NephropathyProspective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy Membranous Nephropathyexperimental group:Rituximab 600mg iv, and supportive treatment;control group:Supportive treatment according to KDIGO guideline;Peking Union Medical College Hospital, Chinese Academy of Medical SciencesNULLRecruiting1870Bothexperimental group:19;control group:19;Phase 4China
9ChiCTR2000040799
2020-05-202020-12-10Prospective study of rituximab combined with low-dose hormone in the treatment of idiopathic membranous nephropathyProspective study of rituximab combined with low-dose hormone in the treatment of idiopathic membranous nephropathy idiopathic membranous nephropathySingle arm:Rituximab;The First Affiliated Hospital, Sun Yat-Sen UniversityNULLRecruiting18BothSingle arm:50;Phase 4China
10EUCTR2019-001734-34-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
11NCT03804359
(ClinicalTrials.gov)
January 14, 202011/1/2019Personalized Medicine for Membranous NephropathyPersonalized Medicine for Membranous NephropathyIdiopathic Membranous NephropathyDrug: RituximabCentre Hospitalier Universitaire de NiceNULLRecruiting18 YearsN/AAll64Phase 2France
12NCT03949855
(ClinicalTrials.gov)
December 18, 201913/5/2019Belimumab With Rituximab for Primary Membranous NephropathyEfficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)Membranous Nephropathy;Nephrotic SyndromeDrug: Belimumab;Drug: Placebo for Belimumab;Drug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);GlaxoSmithKline;PPD;Rho Federal Systems Division, Inc.Recruiting18 Years75 YearsAll124Phase 2United States;Canada
13NCT04154787
(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
14EUCTR2019-001734-34-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
15EUCTR2019-001734-34-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
16EUCTR2019-001734-34-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
17EUCTR2019-001734-34-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
18NCT03763643
(ClinicalTrials.gov)
July 1, 20197/8/2018PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-TransplantPRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-TransplantFocal Segmental GlomerulosclerosisDrug: Rituximab;Procedure: PlasmapheresisUniversity of MinnesotaUnited States Department of DefenseRecruiting1 Year65 YearsAll160Phase 3United States
19EUCTR2018-004611-50-GB
(EUCTR)
14/06/201911/04/2019The Use of Rituximab IN treatment of immune-mediated Glomerulonephritis (TURING) A randomised, two-arm (1:1 ratio), double blind, placebo controlled phase III trial to assess the efficacy, safety, cost and cost-effectiveness of rituximab in treating de novo or relapsing NS in patients with MCD/FSGS (TURING) - TURING Minimal Change Disease (MCD) and Focal segmental glomerulosclerosis (FSGS)Product Name: Rituximab
INN or Proposed INN: Rituximab
Cambridge University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
112 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
20EUCTR2018-003437-15-FR
(EUCTR)
03/04/201927/02/2019Rituximab from the FIRst Episode of Idiopathic Nephrotic SyndromeRituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome - RIFIREINS Minimal Change Nephrotic Syndrome (MCNS)
MedDRA version: 20.0;Level: LLT;Classification code 10029168;Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARISNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
148 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
21NCT03298698
(ClinicalTrials.gov)
August 22, 201824/8/2017Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic SyndromeEfficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose PrednisoneIdiopathic Nephrotic Syndrome;Minimal Change Disease;Focal Segmental GlomerulosclerosisDrug: Rituximab;Drug: PrednisoneRadboud UniversityNULLRecruiting18 YearsN/AAll40Phase 3Netherlands
22NCT03180723
(ClinicalTrials.gov)
July 1, 20173/6/2017Effect of Rituximab in Treatment of Membranoproliferative GlomerulonephritisEffect of Rituximab in Treatment of Primary Membranoproliferative GlomerulonephritisMembranoproliferative GlomerulonephritisDrug: Rituximab;Drug: CyclosporinAssiut UniversityNULLNot yet recruiting18 YearsN/AAll30Phase 3NULL
23NCT02966717
(ClinicalTrials.gov)
August 201630/10/2016Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)The Clinical Study of Rituximab Combined With Mesenchymal Stem Cells in the Treatment of Primary Nephrotic Syndrome (3-4 Stage of Chronic Kidney Disease)Renal Insufficiency, Chronic;Nephrotic SyndromeDrug: Rituximab;Drug: conventional therapy;Drug: Mesenchymal stem cellsZhujiang HospitalNULLActive, not recruiting18 Years65 YearsBoth116Phase 2China
24ChiCTR-IPR-16008527
2016-06-012016-05-24Rituximab in the treatment of refractory membranous nephropathy: a multicenter, randomized, controlled clinical studyRituximab in the treatment of resistant membranous nephropathy: a multicenter, randomized, controlled clinical study Membranous nephropathyCsA group:oral CsA and glucosteroid;RTX group:intravenous RTX;CTX:Intravenous cyclophosphamide and glucosteroid;Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicineNULLCompleted1870BothCsA group:60;RTX group:60;CTX:60;Phase 4China
25JPRN-UMIN000022150
2016/04/3001/05/2016The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome. - The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome. primary nephrotic syndromerituximabTokyo Metropolitan Geriatric HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female50Not applicableJapan
26EUCTR2013-000226-55-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
27NCT01955187
(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
28NCT01573533
(ClinicalTrials.gov)
October 20135/4/2012A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGSA Pilot Study to Assess the Efficacy of Rituximab Therapy in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS): Integrating an Assessment of the Relevance of suPAR and Activation of Podocyte ß3 IntegrinPrimary Focal Segmental GlomerulosclerosisBiological: RituximabMayo ClinicUniversity Health Network, Toronto;National Institutes of Health (NIH);Genentech, Inc.;Rush University Medical Center;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed6 Years80 YearsAll9Phase 2United States;Canada
29EUCTR2011-006115-59-IT
(EUCTR)
11/06/201208/06/2012A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) - GNM-2011 MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp
MedDRA version: 14.1;Level: PT;Classification code 10018372;Term: Glomerulonephritis membranous;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Trade Name: URBASON*IM EV 1F 250MG+1F 5ML
Trade Name: MEDROL*10CPR DIV 4MG
Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
30NCT01164098
(ClinicalTrials.gov)
February 201215/7/2010Rituximab to Prevent Recurrence of ProteinuriaThe Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGSFSGS;ProteinuriaDrug: RituximabGeorge W. BurkeGenentech, Inc.;National Institutes of Health (NIH);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated7 Years65 YearsAll30Phase 3United States
31NCT01508468
(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
32NCT03018535
(ClinicalTrials.gov)
January 20129/1/2017Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous NephropathyA Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous NephropathyGlomerulonephritis, MembranousDrug: Rituximab;Drug: Methylprednisolone;Drug: CyclophosphamideAzienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity of Bari;Azienda Ospedaliera Brotzu;University of Messina;University of Milan;Universita di Verona;University of Chieti;University of Bologna;Azienda Sanitaria Locale Roma E;Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi;Regione Piemonte;University of Modena and Reggio Emilia;University of Pisa;University of Milano Bicocca;Humanitas Hospital, Italy;Azienda Ospedaliera Universitaria Policlinico;Fondazione Salvatore Maugeri;University of Bern;University of Alberta;Istituto Giannina GasliniActive, not recruiting18 YearsN/AAll76Phase 3Italy
33NCT01180036
(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
34JPRN-UMIN000005231
2011/03/0110/03/2011Uncontrol trial of rituximab treatment on steroid dependent and frequently relapsing minimal cahnge nephrotic syndrome(MCNS) steroid dependent and frequently relapsing minimal change nephrotic syndromerituximab 375mg/m2 single-dose
1 time/6months
24 months follow up
Department of Medicine, Kidney Center, Tokyo Women's Medical UniversityNULLComplete: follow-up complete20years-old60years-oldMale and Female50Phase 3Japan
35NCT00977977
(ClinicalTrials.gov)
December 2, 201015/9/2009Rituximab Plus Cyclosporine in Idiopathic Membranous NephropathyRituximab Plus Cyclosporine in Idiopathic Membranous NephropathyNephrotic Syndrome;Proteinuria;Autoimmune Disease;Glomerular Disease;Membranous GlomerulonephritisDrug: Rituximab Infusion;Drug: Oral CyclosporineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLRecruiting18 YearsN/AAll30Phase 2United States
36EUCTR2008-006750-17-IT
(EUCTR)
14/04/200927/01/2009A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMOA prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO Nephrotic Syndrome secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS.
MedDRA version: 9.1;Level: LLT;Classification code 10029171
MedDRA version: 9.1;Classification code 10058326
MedDRA version: 9.1;Classification code 10016832
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly
37NCT00981838
(ClinicalTrials.gov)
April 200921/9/2009Rituximab in Multirelapsing Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS)A Prospective, Sequential Study to Assess the Efficacy of Rituximab Therapy in Maintaining Remission of Nephrotic Syndrome After Steroid and Immunosuppressive Therapy Withdrawal in Patients With Steroid-dependant or Multirelapsing Minimal Change Disease or Focal Segmental Glomerulosclerosis (NEMO Study)Nephrotic SyndromeDrug: RituximabMario Negri Institute for Pharmacological ResearchAgenzia Italiana del FarmacoCompleted2 Years80 YearsBoth24Phase 3Italy
38NCT00550342
(ClinicalTrials.gov)
January 200826/10/2007Rituximab Treatment of Focal Segmental GlomerulosclerosisAnti-CD20, Rituximab, for the Treatment of Recurrent or Primary Resistant Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental Glomerulosclerosis (FSGS)Drug: rituximabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Genentech, Inc.;Indiana UniversityCompleted5 Years60 YearsAll10Phase 2United States
39NCT00405340
(ClinicalTrials.gov)
October 200629/11/2006Rituximab in the Treatment of Idiopathic Membranous NephropathyRituximab in the Treatment of Idiopathic Membranous NephropathyMembranous NephropathyDrug: RituximabMayo ClinicGenentech, Inc.Completed18 YearsN/ABoth20Phase 0United States
40NCT00275613
(ClinicalTrials.gov)
November 200510/1/2006Pilot Study of Rituximab for Membranoproliferative GlomerulonephritisPilot Study of Rituximab for Membranoproliferative GlomerulonephritisGlomerulonephritis, MembranoproliferativeDrug: RituximabMayo ClinicNULLCompleted18 YearsN/ABoth10Phase 1United States
41NCT00425217
(ClinicalTrials.gov)
August 200419/1/2007Rituximab in Membranous NephropathyThe Use of Rituximab in the Treatment of Idiopathic Membranous NephropathyMembranous NephropathyDrug: RituximabMayo ClinicGenentech, Inc.Completed18 YearsN/ABoth15Phase 2/Phase 3United States