222. Primary nephrotic syndrome Clinical trials / Disease details
Clinical trials : 310 / Drugs : 295 - (DrugBank : 117) / Drug target genes : 63 - Drug target pathways : 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 | NCT05183646 (ClinicalTrials.gov) | May 30, 2022 | 29/11/2021 | A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB | A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB) | FSGS | Drug: DMX-200;Drug: Placebo | Dimerix Bioscience Pty Ltd | NULL | Recruiting | 18 Years | 80 Years | All | 286 | Phase 3 | United States;Argentina;Australia;Brazil;Denmark;France;Hong Kong;New Zealand;Spain;Taiwan;United Kingdom |
| 2 | EUCTR2021-004174-64-ES (EUCTR) | 26/05/2022 | 22/12/2021 | Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis | A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) - ACTION3 | Focal segmental glomerulosclerosis MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10016832;Term: Focal & segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Repagermanium Product Code: DMX-200 INN or Proposed INN: Repagermanium | Dimerix Bioscience Pty Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 286 | Phase 3 | France;United States;Taiwan;Hong Kong;Argentina;Brazil;Spain;Denmark;Australia;United Kingdom;New Zealand;Korea, Republic of | ||
| 3 | EUCTR2021-004174-64-DK (EUCTR) | 08/03/2022 | 16/12/2021 | Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis | A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) - ACTION3 | Focal segmental glomerulosclerosis MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10016832;Term: Focal & segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Repagermanium Product Code: DMX-200 INN or Proposed INN: Repagermanium | Dimerix Bioscience Pty Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 286 | Phase 3 | France;United States;Taiwan;Hong Kong;Argentina;Spain;Brazil;Australia;Denmark;United Kingdom;New Zealand | ||
| 4 | EUCTR2020-000971-18-NO (EUCTR) | 28/06/2021 | 23/02/2021 | A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effect | An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003 | Idiopathic membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | Denmark;Norway | ||
| 5 | NCT04183101 (ClinicalTrials.gov) | October 1, 2020 | 14/11/2019 | Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy | Phase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 Glomerulopathy | C3 Glomerulopathy;Membranoproliferative Glomerulonephritis;Complement Abnormality;Dense Deposit Disease;C3 Glomerulonephritis | Drug: Aliskiren;Drug: Enalapril | Region Skane | NULL | Recruiting | 6 Years | N/A | All | 30 | Phase 2 | Sweden |
| 6 | NCT04456816 (ClinicalTrials.gov) | August 31, 2020 | 24/6/2020 | A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria | An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria | Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy;Severe Proteinuria Due to Idiopathic Membranous Nephropathy | Drug: 100 mg AP1189;Drug: Placebo | SynAct Pharma Aps | NULL | Recruiting | 18 Years | 85 Years | All | 23 | Phase 2 | Denmark |
| 7 | EUCTR2020-000971-18-DK (EUCTR) | 28/05/2020 | 04/04/2020 | A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effect | An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003 | Idiopathic membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: AP1189 INN or Proposed INN: Not applicable | SynAct Pharma ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | Denmark | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | EUCTR2016-005141-23-HR (EUCTR) | 25/07/2019 | 11/10/2019 | 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 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 | Retrophin, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Argentina;Hong Kong;Hungary;United States;United Kingdom;Portugal;Spain;New Zealand;Canada;Czech Republic;Sweden;Belgium;Taiwan;Brazil;Denmark;Korea, Republic of;Poland;Italy;Australia;France;Germany;Croatia;Estonia | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | EUCTR2016-005141-23-PL (EUCTR) | 20/11/2018 | 25/06/2018 | 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 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 | Retrophin, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Estonia;Argentina;Hong Kong;Hungary;United States;United Kingdom;Portugal;Spain;New Zealand;Canada;Czech Republic;Sweden;Belgium;Taiwan;Poland;Brazil;Denmark;Korea, Republic of;Italy;Australia;France;Germany;Croatia | ||
| 15 | 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 | ||
| 16 | EUCTR2016-005141-23-ES (EUCTR) | 28/09/2018 | 21/06/2018 | 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: 20.0;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 Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03 Product Name: over-encapsulated 75 mg Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Retrophin, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Denmark;South Africa;Germany;Korea, Republic of | ||
| 17 | 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 | ||
| 18 | EUCTR2016-005141-23-IT (EUCTR) | 17/09/2018 | 15/01/2021 | 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) - Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis ( | 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 Product Code: [R-021] Trade Name: Irbesartan Product Name: IRBESARTAN Product Code: [SUB08293MIG] Trade Name: Irbesartan tablets Product Name: over-encapsulated Irbesartan Product Code: [over-encapsulated Irbesartan] INN or Proposed INN: Irbesartan Other descriptive name: Irbesartan | RETROPHIN, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Estonia;Spain;Italy;Switzerland;France;Australia;Denmark;South Africa;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Germany;New Zealand;Sweden | ||
| 19 | 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 | ||
| 20 | EUCTR2016-005141-23-HU (EUCTR) | 29/08/2018 | 26/06/2018 | 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: 20.0;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 Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03 Product Name: over-encapsulated 75 mg Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Retrophin, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Sweden;Korea, Republic of | ||
| 21 | NCT03493685 (ClinicalTrials.gov) | April 17, 2018 | 3/4/2018 | Study of Sparsentan 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 FSGS | Focal Segmental Glomerulosclerosis | Drug: sparsentan;Drug: Irbesartan | Travere Therapeutics, Inc. | NULL | Active, not recruiting | 8 Years | 75 Years | All | 371 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Italy;Korea, Republic of;New Zealand;Poland;Portugal;Spain;Sweden;Taiwan;United Kingdom;Hungary |
| 22 | EUCTR2014-002358-38-CZ (EUCTR) | 28/04/2015 | 14/10/2014 | PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY | PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY | 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 Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Aprovel (150 mg) Product Name: Aprovel 150 mg 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 | 100 | Phase 2 | Czechia;Czech Republic;Belgium;Italy | ||
| 23 | EUCTR2014-002358-38-BE (EUCTR) | 05/02/2015 | 25/11/2014 | PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY | PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY | FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) MedDRA version: 17.1;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 Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Aprovel (150 mg) Product Name: Aprovel 150 mg Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Retrophin, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Czech Republic;Belgium;Italy | |||
| 24 | EUCTR2014-002358-38-IT (EUCTR) | 15/12/2014 | 19/11/2014 | PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY | PROTOCOL RET-D-001: EFFICACY AND SAFETY OF SPARSENTAN (RE-021), A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, IN PATIENTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS): A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL, DOSE-ESCALATION STUDY | FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) MedDRA version: 17.1;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 Product Code: RE-021 Trade Name: Aprovel (150 mg) Product Name: Aprovel 150 mg Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN | Retrophin, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Czech Republic;Belgium;Italy | |||
| 25 | NCT01613118 (ClinicalTrials.gov) | March 2014 | 4/6/2012 | Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis | Efficacy and Safety of RE-021, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study | Focal Segmental Glomerulosclerosis | Drug: RE-021 (Sparsentan);Drug: Irbesartan | Travere Therapeutics, Inc. | NULL | Active, not recruiting | 8 Years | 75 Years | All | 109 | Phase 2 | United States;Czechia;Italy;Belgium;Czech Republic |
| 26 | NCT01508468 (ClinicalTrials.gov) | January 17, 2012 | 9/12/2011 | Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy | Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: 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 Paris | NULL | Completed | 18 Years | N/A | All | 80 | Phase 3 | France |
| 27 | JPRN-UMIN000000621 | 2007/03/01 | 28/02/2007 | Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission | Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission - ONTRACK | Minimal change nephrotic syndrome | Prednisolone (+), combination therapy (-) Prednisolone (+), combination therapy (+) | Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 50 | Not selected | Japan |