222. 一次性ネフローゼ症候群 Primary nephrotic syndrome Clinical trials / Disease details
臨床試験数 : 310 / 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-004864-81-IT (EUCTR) | 17/12/2021 | 17/09/2021 | 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) | 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 NEGRI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 2 | NCT04629248 (ClinicalTrials.gov) | June 25, 2021 | 27/10/2020 | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy | A 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 | Drug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 140 | Phase 3 | United States;Argentina;Brazil;China;France;Israel;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine;Peru |
| 3 | EUCTR2020-003233-38-PL (EUCTR) | 13/04/2021 | 24/02/2021 | A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Peru;China | ||
| 4 | EUCTR2020-003233-38-IT (EUCTR) | 06/04/2021 | 04/06/2021 | A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;France;Canada;Argentina;Brazil;Poland;Peru;China |