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 : 61 - 標的パスウェイ数 : 190

  
28 trials found
No.TrialIDDate_
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PhaseCountries
1ChiCTR2100048518
2021-10-312021-07-09A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathyA prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy idiopathic membranous nephropathylow-dose multi-target group:No;tacrolimus combined with belimumab sequential group:No;intravenous cyclophosphamide pulse group:No;The Second Affiliated Hospital of Xi'an Jiaotong UniversityNULLPending1870Bothlow-dose multi-target group:100;tacrolimus combined with belimumab sequential group:100;intravenous cyclophosphamide pulse group:100;China
2NCT04629248
(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
3EUCTR2020-003233-38-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
4EUCTR2020-003233-38-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
5ChiCTR2000032422
2020-09-012020-04-27The efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world studyThe efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world study Idiopathic membranous nephropathyexperimental group:Tacrolimus;control group:conservative treatment;Shenzhen Second People's HospitalNULLPendingBothexperimental group:24;control group:24;Phase 4Chiina
6ChiCTR2000033766
2020-07-012020-06-11Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimusDiagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus Membranous nephropathy1:Prednisone + cyclophosphamide;2:Prednisone + Tacrolimus;The First Affiliated Hospital of Bengbu Medical CollegeNULLPending1770Both1:30;2:30;Phase 4China
7ChiCTR2000031003
2020-03-252020-03-20Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimenStudy and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen Idiopathic focal segmental glomerulosclerosisTacrolimus group:Low dose of tacrolimus combined with hormone;hormone group:Use hormones;Southwest Hospital, the First Affiliated Hospital of Army Medical UniversityNULLRecruitingBothTacrolimus group:19;hormone group:19;Phase 4China
8ChiCTR1900022943
2019-05-032019-05-04Population Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic SyndromePopulation Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic Syndrome Nephrotic SyndromeCase Series:Tacrolimus;Children's Hospital, Zhejiang University School of MedicineNULLRecruitingBothCase Series:100;Phase 4China
9NCT03864250
(ClinicalTrials.gov)
November 26, 20184/3/2019Tacrolimus Monotherapy for Idiopathic Membranous NephropathyTacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical TrialTacrolimus;Idiopathic Membranous Nephropathy;Clinical TrialDrug: Tacrolimus;Drug: PrednisoneXinhua Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruiting18 Years80 YearsAll124N/AChina
10NCT03549663
(ClinicalTrials.gov)
July 4, 201810/5/2018Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)Idiopathic Membranous NephropathyDrug: Tacrolimus;Drug: PrednisoneXinhua Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruiting18 Years80 YearsAll108N/AChina
11ChiCTR1800016140
2018-07-012018-05-14Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open studyA randomized controlled trial for the treatment of primary membranous nephropathy primary membranous nephropathyTacrolimus group:Tacrolimus 0.05-0.1mg/kg/d;Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks;Sichuan Provincial People's HospitalNULLPending1865BothTacrolimus group:45;Cyclophosphamide group:45;China
12ChiCTR1800014719
2018-02-012018-01-31A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosisA retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis idiopathic focal segmental glomerulosclerosistacrolimus group:nothing;prednisone group:nothing;the First Affiliated Hospital of Third Military Medical UniversityNULLRecruitingBothtacrolimus group:24;prednisone group:17;China
13NCT02921789
(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
14ChiCTR-IPR-16008344
2016-04-192016-04-22A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid plus tacrolimus in idiopathic membranous nephropathyA study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid Plus tacrolimus in idiopathic membranous nephropathy idiopathic membranous nephropathyA:cyclophosphamide ;B:tacrolimus;Baoji Central HospitalNULLRecruitingBothA:30;B:30;China
15EUCTR2013-000226-55-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
16NCT01955187
(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
17NCT01763580
(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
18NCT01451489
(ClinicalTrials.gov)
October 13, 20115/8/2011The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental GlomerulosclerosisA Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental GlomerulosclerosisFSGSDrug: FK506;Drug: CyclophosphamideNanjing University School of MedicineNULLTerminated14 Years65 YearsAll70N/AChina
19ChiCTR-TRC-11001454
2011-08-012011-08-08Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trialTacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial minimal change disease in adults;ICD10:N04.001Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape;Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityNULLCompletedBothGroup A:60;Group B:60;China
20NCT01162005
(ClinicalTrials.gov)
July 201012/7/2010Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in ChildrenTherapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in ChildrenNephrotic SyndromeDrug: TacrolimusSeoul National University HospitalChong Kun Dang PharmaceuticalCompletedN/A18 YearsAll77Phase 4Korea, Republic of
21NCT01161459
(ClinicalTrials.gov)
June 201012/7/2010Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus SteroidResearch Institute of Nephrology, Jinling HospitalIdiopathic Membranous NephropathyDrug: Tripterygium wilfordii;Drug: FK506Zhi-Hong Liu, M.D.NULLCompleted18 Years65 YearsBoth100N/AChina
22EUCTR2007-005410-39-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
23ChiCTR-TRC-10001024
2008-01-012010-09-14Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosisTacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis primary focal segmental glomerulosclerosisgroup A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ;Shanghai Jiaotong University Affiliated Ruijin HospitalNULLCompleted1875Bothgroup A:30;group B:30;China
24NCT00302536
(ClinicalTrials.gov)
March 200613/3/2006Tacrolimus Treatment of Patients With Idiopathic Focal Segmental GlomerulosclerosisTacrolimus Treatment of Patients With Idiopathic Focal SegmentalFocal GlomerulosclerosisDrug: TacrolimusNanjing University School of MedicineNULLWithdrawn15 Years50 YearsBoth0N/AChina
25NCT00302523
(ClinicalTrials.gov)
March 200613/3/2006Tacrolimus Treatment of Patients With Idiopathic Membranous NephropathyTacrolimus Treatment of Patients With IdiopathicIdiopathic Membranous NephropathyDrug: TacrolimusNanjing University School of MedicineNULLCompleted18 Years60 YearsBoth16N/AChina
26NCT00362531
(ClinicalTrials.gov)
November 20049/8/2006Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic SyndromePhase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic SyndromeIdiopathic Membranous Nephropathy;Nephrotic SyndromeDrug: tacrolimus combined with prednisonePeking UniversityNULLCompleted18 Years70 YearsBothPhase 2/Phase 3NULL
27ChiCTR-TRC-09000539
2004-03-012009-09-30Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapyClinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy Nephrotic DiseaseS:Patients receive tacrolimus combined with prednison for six months;L:Patients receive tacrolimus combined with prednison for 24 months;Second Hospital of Jilin UniversityNULLCompleted1669BothS:10;L:10;China
28EUCTR2015-001039-18-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