222. 一次性ネフローゼ症候群 [臨床試験数:234,薬物数:241(DrugBank:78),標的遺伝子数:59,標的パスウェイ数:185

Searched query = "Primary nephrotic syndrome", "Minimal change nephrotic syndrome", "MCNS", "Membranous nephropathy", "Focal segmental glomerulosclerosis", "FSGS", "Membranoproliferative glomerulonephritis", "MPGN"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
35 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR20000325232020-06-012020-05-01Efficacy 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;China
2ChiCTR20000335402020-06-012020-06-04Prospective 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;China
3EUCTR2019-001734-34-NL07/04/202022/08/2019Efficacy 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: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem 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 2France;United States;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Germany;Netherlands;United Kingdom;India
4NCT03804359January 14, 202011/1/2019Personalized Medicine for Membranous NephropathyPersonalized Medicine for Membranous NephropathyIdiopathic Membranous NephropathyDrug: RituximabCentre Hospitalier Universitaire de NiceNULLRecruiting18 YearsN/AAll64Phase 2France
5NCT03970577January 14, 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 ParisNULLActive, not recruiting18 YearsN/AAll148Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03949855December 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;MNDrug: Belimumab;Drug: Placebo for Belimumab;Drug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);GlaxoSmithKlineRecruiting18 Years75 YearsAll124Phase 2United States;Canada
7NCT04154787November 23, 20198/10/2019Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous NephropathyA 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 NephropathyGlomerulonephritis, MembranousDrug: LNP023;Drug: RituximabNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll72Phase 2Argentina;Czechia;France;Germany;India;Netherlands;Singapore;Spain;United Kingdom
8EUCTR2019-001734-34-ES12/11/201904/09/2019Efficacy 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]
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
9EUCTR2019-001734-34-FR23/10/201913/09/2019Efficacy 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
10EUCTR2019-001734-34-GB23/09/201907/08/2019Efficacy 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: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03763643July 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;Drug: Placebo;Procedure: PlasmapheresisUniversity of MinnesotaUnited States Department of DefenseRecruiting1 Year40 YearsAll160Phase 1/Phase 2United States
12EUCTR2018-004611-50-GB14/06/201911/04/2019The 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)Cambridge University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
112 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited Kingdom
13EUCTR2018-003437-15-FR03/04/201927/02/2019Rituximab 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]
ASSISTANCE PUBLIQUE - HOPITAUX DE PARISNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
148 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance
14NCT03298698August 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
15NCT03180723July 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02966717August 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
17ChiCTR-IPR-160085272016-06-012016-05-24Rituximab 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;Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicineNULLRecruiting1870BothCsA group:60;RTX group:60;China
18JPRN-UMIN0000221502016/04/3001/05/2016The 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 appl1cableJapan
19EUCTR2013-000226-55-NL04/03/201524/06/2014SEQUENTIAL 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: 17.0Level: LLTClassification code 10027170Term: Membranous nephropathySystem 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
20NCT01955187January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01573533October 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
22EUCTR2011-006115-59-IT11/06/201208/06/2012A 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: 14.1Level: PTClassification code 10018372Term: Glomerulonephritis membranousSystem 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
23NCT01164098February 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
24NCT01508468January 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 ParisNULLActive, not recruiting18 YearsN/ABoth80Phase 3France
25NCT03018535January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01180036November 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
27JPRN-UMIN0000052312011/03/0110/03/2011Uncontrol 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
28NCT00977977December 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 Years100 YearsAll30Phase 2United States
29EUCTR2008-006750-17-IT14/04/200927/01/2009A 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 Level: LLT Classification code 10058326
MedDRA version: 9.1 Level: LLT Classification code 10016832
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noItaly
30NCT00981838April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00550342January 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
32NCT00405340October 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
33NCT00275613November 200510/1/2006Pilot Study of Rituximab for Membranoproliferative GlomerulonephritisPilot Study of Rituximab for Membranoproliferative GlomerulonephritisGlomerulonephritis, MembranoproliferativeDrug: RituximabMayo ClinicNULLCompleted18 YearsN/ABoth10Phase 1United States
34NCT00425217August 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
35EUCTR2019-001734-34-DE12/09/2019Efficacy 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: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem 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