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 | EUCTR2016-005141-23-PT (EUCTR) | 23/09/2019 | 12/04/2019 | Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: Over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 2 | EUCTR2016-005141-23-SE (EUCTR) | 31/07/2019 | 28/03/2019 | Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: Over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Korea, Republic of;Sweden | ||
| 3 | EUCTR2016-005141-23-BE (EUCTR) | 15/07/2019 | 14/05/2019 | Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: Over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 4 | EUCTR2016-005141-23-DE (EUCTR) | 28/05/2019 | 30/05/2018 | Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablet Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (NDC# 43547-0374-03 and NDC 43547-374-09, approved in the USA) Generic tablets distributed by Solco Healthcare US, LLC Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (NDC# 31722-729-30 approved in the United states) Product Name: Over-encapsulated Irbesartan Tablets Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 5 | EUCTR2016-005141-23-EE (EUCTR) | 07/05/2019 | 27/03/2019 | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: Over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Czechia;Taiwan;Estonia;Hong Kong;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 6 | EUCTR2016-005141-23-DK (EUCTR) | 05/11/2018 | 02/08/2018 | Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: Over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Czechia;Hong Kong;Taiwan;Estonia;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Denmark;Australia;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 7 | EUCTR2016-005141-23-GB (EUCTR) | 18/09/2018 | 02/05/2018 | Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) - DUPLEX (021FSGS16010) Sparsentan in FSGS | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: Irbesartan tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: Irbesartan tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN | Retrophin, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 8 | EUCTR2016-005141-23-CZ (EUCTR) | 05/09/2018 | 13/06/2018 | Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS) | A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) | Focal segmental glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Sparsentan/Over-encapsulated Sparsentan tablets Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets Product Name: Over-encapsulated Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Travere Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Czechia;Estonia;Hong Kong;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Australia;Denmark;Germany;New Zealand;Sweden;Korea, Republic of |