218. アルポート症候群
［臨床試験数：16，薬物数：24（DrugBank：11），標的遺伝子数：5，標的パスウェイ数：27］
Searched query = "Alport syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | 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 | Not yet recruiting | 18 Years | N/A | All | 80 | Phase 2 | NULL |
| 2 | 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 |
| 3 | 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 | |
| 4 | NCT02855268 (ClinicalTrials.gov) | November 2, 2019 | 28/7/2016 | Study of SAR339375 in Patients With Alport Syndrome | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of 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 | Recruiting | 18 Years | 55 Years | All | 45 | Phase 2 | United States;Australia;China;France;Germany;Spain;United Kingdom |
| 5 | 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;Australia;Japan;Puerto Rico |
| 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 |
| 6 | 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 continuing | 12years-old | 70years-old | Male and Female | 180 | Phase 2;Phase 3 | Japan,North America,Australia,Europe |
| 7 | 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] | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | France;United States;Canada;Spain;Australia;Germany;United Kingdom | |||
| 8 | 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 |
| 9 | 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] | Reata Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | France;United States;Canada;Spain;Australia;Germany;United Kingdom | |||
| 10 | 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 | ||
| 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 |
| 11 | 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 |
| 12 | 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] | Regulus Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;United States;Canada;Spain;Australia;Germany;United Kingdom | |||
| 13 | 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 |
| 14 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Germany | |||
| 15 | 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 |
| 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 |
| 16 | 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 | Alport Syndrome;Hereditary Kidney Disease;Pediatric Kidney Disease;Thin Basement Membrane Disease;Familial Benign Hematuria | 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 |