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 | NCT04893096 (ClinicalTrials.gov) | October 22, 2021 | 11/5/2021 | Rescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target Therapy | Rescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target Therapy | Membranous Nephropathy | Drug: MOR202 | Mario Negri Institute for Pharmacological Research | MorphoSys AG | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 2 | Italy |
| 2 | EUCTR2021-000835-30-IT (EUCTR) | 12/10/2021 | 30/08/2021 | MOR202 for refractory MN | RESCUE THERAPY WITH THE HUMAN ANTI-CD38 ANTIBODY MOR202 (FELZARTAMAB) IN PATIENTS WITH MEMBRANOUS NEPHROPATHY WHO FAILED ANTI-CD20 TARGETED THERAPY: A PILOT, PROOF-OF-CONCEPT STUDY - MOR202 for refractory MN | Membranous Nephropathy who Failed Anti-CD20 Target Therapy. MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Product Name: MOR202 Product Code: [MOR202] | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Italy | ||
| 3 | EUCTR2019-000780-24-PL (EUCTR) | 07/01/2021 | 14/09/2020 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: felzartamab Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Belgium;Spain;Poland;Australia;Netherlands;Italy;Korea, Republic of | ||
| 4 | EUCTR2020-002985-15-DE (EUCTR) | 21/12/2020 | 31/08/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) 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 Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 5 | EUCTR2020-002985-15-GR (EUCTR) | 22/10/2020 | 11/09/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) 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 Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | Human Immunology Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 6 | EUCTR2020-002985-15-GB (EUCTR) | 12/10/2020 | 25/08/2020 | Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) | A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE | Anti-PLA2R antibody positive membranous nephropathy (aMN) 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 Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | Phase 2 | Taiwan;Greece;Australia;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of | ||
| 7 | EUCTR2019-000780-24-ES (EUCTR) | 25/10/2019 | 26/07/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Netherlands | ||
| 8 | NCT04145440 (ClinicalTrials.gov) | October 15, 2019 | 18/10/2019 | Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN) | Glomerulonephritis, Membranous;antiPLA2R Positive | Drug: MOR202 | MorphoSys AG | NULL | Completed | 18 Years | 80 Years | All | 31 | Phase 1/Phase 2 | United States;Australia;Belgium;France;Italy;Korea, Republic of;Netherlands;Poland;Spain |
| 9 | EUCTR2019-000780-24-IT (EUCTR) | 08/10/2019 | 22/01/2020 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Spain;Netherlands;Italy | ||
| 10 | EUCTR2019-000780-24-NL (EUCTR) | 24/09/2019 | 03/07/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1;Phase 2 | France;United States;European Union;Poland;Spain;Australia;Netherlands;Italy;Korea, Republic of | ||
| 11 | EUCTR2019-000780-24-FR (EUCTR) | 23/09/2019 | 15/10/2019 | Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE | Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087 | MorphoSys AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;European Union;Spain;Netherlands |