218. アルポート症候群 Alport syndrome Clinical trials / Disease details
臨床試験数 : 26 / 薬物数 : 33 - (DrugBank : 13) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 29
| 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 | NCT05267262 (ClinicalTrials.gov) | March 15, 2022 | 23/2/2022 | Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental Glomerulosclerosis | A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in AS Patients With Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients With Primary Steroid-Resistant FSGC | Alport Syndrome;Focal Segmental Glomerulosclerosis | Drug: R3R01 | River 3 Renal Corp. | IQVIA Biotech | Not yet recruiting | 12 Years | N/A | All | 50 | Phase 2 | NULL |
| 2 | EUCTR2021-000621-27-IT (EUCTR) | 11/01/2022 | 12/10/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;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 | TRAVERE THERAPEUTICS, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | NCT05133050 (ClinicalTrials.gov) | January 1, 2022 | 27/10/2021 | Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants | Safety and Efficacy of Early Angiotensin-converting Enzyme Inhibition in Patients With Alport Syndrome Carrying Pathogenic Heterozygous COL4A3,COL4A4 or COL4A5 Mutations | Alport Syndrome | Drug: Ramipril | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Not yet recruiting | 30 Years | 50 Years | All | 510 | N/A | China |
| 4 | EUCTR2021-000621-27-ES (EUCTR) | 08/10/2021 | 27/07/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;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 | Travere Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 57 | Phase 2 | Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;France;United States;Poland | ||
| 5 | NCT04937907 (ClinicalTrials.gov) | September 8, 2021 | 17/6/2021 | Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS) | Efficacy and Safety of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS) | Alport Syndrome, X-Linked | Drug: Hydroxychloroquine Sulfate 100 milligram (mg) Tab;Drug: Benazepril hydrochloride 10 milligram (mg) Tab | Shanghai Children's Hospital | NULL | Recruiting | 3 Years | 18 Years | All | 50 | Phase 2 | China |
| 6 | NCT05003986 (ClinicalTrials.gov) | August 12, 2021 | 29/7/2021 | Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular Diseases | Focal Segmental Glomerulosclerosis;Minimal Change Disease;Immunoglobulin A Nephropathy;Immunoglobulin A-Associated Vasculitis;Alport Syndrome | Drug: Sparsentan | Travere Therapeutics, Inc. | NULL | Recruiting | 1 Year | 17 Years | All | 57 | Phase 2 | United States;Poland;Spain |
| 7 | NCT04573920 (ClinicalTrials.gov) | February 1, 2021 | 28/9/2020 | Atrasentan in Patients With Proteinuric Glomerular Diseases | A Phase 2, Open-Label, Basket Study of Atrasentan in Patients With Proteinuric Glomerular Diseases | IgA Nephropathy;Focal Segmental Glomerulosclerosis;Alport Syndrome;Diabetic Kidney Disease;Diabetic Nephropathy Type 2;Immunoglobulin A Nephropathy | Drug: Atrasentan | Chinook Therapeutics U.S., Inc. | NULL | Recruiting | 18 Years | N/A | All | 80 | Phase 2 | United States;Australia;Italy;Korea, Republic of;Spain;United Kingdom |
| 8 | ChiCTR2000036799 | 2020-10-01 | 2020-08-25 | Construction and clinical transformation of integrated platform for accurate diagnosis and treatment of Alport syndrome | Construction and clinical transformation of integrated platform for accurate diagnosis and treatment of Alport syndrome | Alport Syndrome | experimental group:Hydroxychloroquine + Benazepril Hydrochloridec;control group:placebo + benazepril hydrochloride; | Shanghai Children's Hospital | NULL | Pending | 0 | 18 | Both | experimental group:25;control group:25; | N/A | China |
| 9 | ChiCTR2000036550 | 2020-09-01 | 2020-08-24 | Enzyme-linked immunosorbent determination of urine IV collagen alpha chain early warning value for Alport syndrome | Enzyme-linked immunosorbent determination of urine IV collagen alpha chain early warning value for Alport syndrome | Alport syndrome | Gold Standard:Renal biopsy, skin biopsy and genetic test.;Index test:urine IV collagen a chain test; | Children's Hospital of Shanghai | NULL | Recruiting | 0 | 18 | Both | Target condition:60;Difficult condition:70 | China | |
| 10 | EUCTR2019-004394-10-DE (EUCTR) | 30/06/2020 | 09/12/2019 | Study of lademirsen (SAR339375) in patients with Alport Syndrome | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients with Alport Syndrome - HERA | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Lademirsen Product Code: SAR339375 Other descriptive name: RG-012 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | France;United States;Spain;Australia;Germany;United Kingdom;China | ||
| 11 | NCT02855268 (ClinicalTrials.gov) | November 2, 2019 | 28/7/2016 | Study of Lademirsen (SAR339375) in Patients With Alport Syndrome | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients With Alport Syndrome | Alport's Syndrome | Drug: lademirsen (SAR339375);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 18 Years | 55 Years | All | 43 | Phase 2 | United States;Australia;Canada;China;France;Germany;Spain;United Kingdom |
| 12 | NCT03749447 (ClinicalTrials.gov) | March 8, 2019 | 19/11/2018 | An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease | Chronic Kidney Diseases;Alport Syndrome;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl | Reata Pharmaceuticals, Inc. | NULL | Recruiting | 12 Years | N/A | All | 480 | Phase 3 | United States;Puerto Rico;Japan;Australia |
| 13 | JPRN-UMIN000032448 | 2018/05/01 | 01/05/2018 | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome | Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status. Dosing period is up to 2 years. Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 2 years. | Reata Pharmaceuticals, Inc | NULL | Complete: follow-up complete | 12years-old | 70years-old | Male and Female | 180 | Phase 2/3 | Japan,North America,Australia,Europe |
| 14 | EUCTR2016-004395-22-GB (EUCTR) | 28/03/2018 | 31/10/2017 | clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Australia;Germany;United Kingdom | ||
| 15 | NCT03373786 (ClinicalTrials.gov) | December 22, 2017 | 22/10/2017 | A Study of RG-012 in Subjects With Alport Syndrome | A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of RG-012 for Injection, Including Its Effect on Renal microRNA-21, in Subjects With Alport Syndrome | Alport Syndrome | Drug: RG012 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 65 Years | All | 4 | Phase 1 | United States |
| 16 | EUCTR2016-004395-22-DE (EUCTR) | 19/12/2017 | 25/09/2017 | clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;France;Canada;Spain;Australia;Germany;United Kingdom | ||
| 17 | EUCTR2016-004395-22-FR (EUCTR) | 04/12/2017 | 05/12/2017 | clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndrome | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL | Alport Syndrome MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2;Phase 3 | United States;France;Canada;Spain;Australia;Germany;United Kingdom | ||
| 18 | NCT03019185 (ClinicalTrials.gov) | March 2, 2017 | 6/1/2017 | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL | A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome | Alport Syndrome | Drug: Placebo Oral Capsule;Drug: Bardoxolone Methyl | Reata Pharmaceuticals, Inc. | NULL | Completed | 12 Years | 60 Years | All | 187 | Phase 2/Phase 3 | United States;Australia;France;Germany;Japan;Puerto Rico;Spain;United Kingdom;Canada |
| 19 | EUCTR2016-002181-32-GB (EUCTR) | 07/12/2016 | 08/09/2016 | A research study to evaluate the safety and effectiveness of RG-012 as a treatment for patients with Alport syndrome | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Dose Selection, and Preliminary Efficacy of Weekly RG 012 Injections in Patients with Alport Syndrome - A Phase 2 Study to Evaluate Weekly RG012 Injections in Alport Syndrome | Alport syndrome is an inherited form of kidney disease caused by mutations in genes coding for the capillary basement membrane collagen IV;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: RG-012 | Regulus Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Australia;Germany;United Kingdom | ||
| 20 | NCT01485978 (ClinicalTrials.gov) | March 2012 | 2/12/2011 | Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome | Early Prospective Therapy Trial to Delay Renal Failure in Children With Alport Syndrome | Renal Insufficiency, Chronic | Drug: Ramipril;Drug: placebo to ramipril | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH | University Medical Center Goettingen;German Federal Ministry of Education and Research | Completed | 24 Months | 18 Years | All | 66 | Phase 3 | Germany |
| 21 | EUCTR2010-024300-10-DE (EUCTR) | 27/02/2012 | 12/12/2011 | Early prospective therapy trial to delay renal failure in children with Alport syndrome. - EARLY PRO-TECT Alport | Early prospective therapy trial to delay renal failure in children with Alport syndrome. - EARLY PRO-TECT Alport | Alport's syndrome MedDRA version: 19.1;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Delix Product Name: Delix Other descriptive name: RAMIPRIL | University Medical Center Göttingen | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | Germany | ||
| 22 | NCT00309257 (ClinicalTrials.gov) | January 2004 | 30/3/2006 | Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport Syndrome | Effects of an Intensified Treatment With ACE-inhibitors, Angiotensin II Receptor Antagonists and Statins in Alport Syndrome | Alport Syndrome | Drug: ACE I, ATA II and Statins;Drug: Benazepril, Valsartan and Fluvastatin | Mario Negri Institute for Pharmacological Research | NULL | Completed | 15 Years | 70 Years | Both | 9 | Phase 2 | Italy |
| 23 | NCT02378805 (ClinicalTrials.gov) | July 1995 | 26/2/2015 | European Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome | European Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome: Current and Novel Therapies | Thin Basement Membrane Disease;Familial Benign Hematuria;Alport Syndrome;Hereditary Kidney Disease;Pediatric Kidney Disease | Drug: ACE-inhibitor;Drug: AT1-inhibitor;Drug: HMG-Coenzyme inhibitor (statin);Drug: Spironolactone;Drug: Paricalcitol | University Hospital Goettingen | Society for Pediatric Nephrology (Germany);Deutsche Gesellschaft für Nephrologie;Alport Selbsthilfe e.V.;Association pour l'Information et la Recherche sur les Maladies Rénales Génétiques (AIRG);KfH Foundation Preventive Medicine | Recruiting | N/A | N/A | All | 500 | Germany | |
| 24 | EUCTR2021-000621-27-PL (EUCTR) | 01/09/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;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 | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 25 | EUCTR2021-000621-27-DE (EUCTR) | 08/09/2021 | Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases. | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;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 | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 26 | EUCTR2021-000621-27-NL (EUCTR) | 14/12/2021 | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).P/024/2021 - EPPIK | Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;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 | Travere Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 57 | Phase 2 | France;United States;Spain;Poland;Germany;Netherlands;United Kingdom;Italy;Sweden |