Bardoxolone methyl (DrugBank: Bardoxolone methyl, Bardoxolone)
7 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 66 | IgA腎症 | 1 |
| 67 | 多発性嚢胞腎 | 9 |
| 84 | サルコイドーシス | 1 |
| 85 | 特発性間質性肺炎 | 1 |
| 86 | 肺動脈性肺高血圧症 | 9 |
| 218 | アルポート症候群 | 6 |
| 222 | 一次性ネフローゼ症候群 | 1 |
| 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 | NCT03366337 (ClinicalTrials.gov) | December 26, 2017 | 4/12/2017 | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases | IgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 103 | Phase 2 | United States |
| 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 | EUCTR2018-004651-20-GB (EUCTR) | 13/02/2020 | 07/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg 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 | 300 | Phase 3 | United States;France;Czech Republic;Spain;Belgium;Australia;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2018-004651-20-DE (EUCTR) | 20/01/2020 | 07/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg 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 | 300 | Phase 3 | United States;France;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2018-004651-20-CZ (EUCTR) | 12/12/2019 | 23/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bardoxolone methyl 5 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 10 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 20 mg Product Code: RTA 402 INN or Proposed INN: Bardoxolone Methyl Other descriptive name: BARDOXOLONE METHYL Product Name: Bardoxolone methyl 15 mg 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 | 300 | Phase 3 | United States;France;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-004651-20-ES (EUCTR) | 19/11/2019 | 04/09/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;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 | 300 | Phase 3 | France;United States;Czech Republic;Belgium;Spain;Australia;Germany;Italy;United Kingdom | |||
| 5 | EUCTR2018-004651-20-BE (EUCTR) | 14/10/2019 | 29/08/2019 | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney Disease | A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON | Autosomal dominant polycystic kidney disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;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 | 300 | Phase 3 | France;United States;Czech Republic;Spain;Belgium;Australia;Germany;Italy;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 |
| 6 | NCT03918447 (ClinicalTrials.gov) | May 29, 2019 | 12/4/2019 | A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON | A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney;ADPKD | Drug: Bardoxolone methyl oral capsule;Drug: Placebo oral capsule | Reata Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 300 | Phase 3 | United States;Australia;Belgium;Czechia;France;Germany;Italy;Japan;Spain;United Kingdom |
| 7 | JPRN-UMIN000039943 | 2019/03/08 | 25/03/2020 | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease | An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease - A Trial of Bardoxolone Methyl in Patients with Chronic Kidney Disease - EAGLE | Chronic Kidney DiseaseAlport SyndromeAutosomal Dominant Polycystic Kidney | Bardoxolone methyl | Reata Pharmaceuticals, Inc. | Kyowa Kirin Co., Ltd. | Recruiting | Not applicable | Not applicable | Male and Female | 180 | Phase 3 | Japan,North America,Australia,Europe |
| 8 | 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 |
| 9 | NCT03366337 (ClinicalTrials.gov) | December 26, 2017 | 4/12/2017 | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases | IgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 103 | Phase 2 | United States |
| 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 | NCT02036970 (ClinicalTrials.gov) | May 2014 | 13/1/2014 | Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT | A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal Fibroelastosis | Drug: Bardoxolone methyl;Drug: Placebo | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 166 | Phase 2 | United States;Germany;Spain;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02036970 (ClinicalTrials.gov) | May 2014 | 13/1/2014 | Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT | A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal Fibroelastosis | Drug: Bardoxolone methyl;Drug: Placebo | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 166 | Phase 2 | United States;Germany;Spain;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-000196-24-GB (EUCTR) | 18/10/2016 | 28/11/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 2 | EUCTR2016-000196-24-BE (EUCTR) | 17/10/2016 | 11/07/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | |||
| 3 | EUCTR2016-000196-24-NL (EUCTR) | 10/10/2016 | 13/07/2016 | BADOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 4 | NCT02657356 (ClinicalTrials.gov) | October 4, 2016 | 13/1/2016 | Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Drug: Placebo capsules;Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Terminated | 18 Years | 75 Years | All | 202 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Germany;Israel;Japan;Mexico;Netherlands;Philippines;Spain;United Kingdom;Chile;Czech Republic |
| 5 | JPRN-UMIN000025158 | 2016/09/01 | 07/12/2016 | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension - A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated to a maximum of 10 mg. Dosing period is up to 6 months. Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 6 months. | Reata Pharmaceuticals, Inc. | NULL | Complete: follow-up complete | 18years-old | 75years-old | Male and Female | 20 | Phase 3 | Japan,North America,South America,Australia,Europe |
| 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 | EUCTR2016-000196-24-CZ (EUCTR) | 30/08/2016 | 18/07/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | ||
| 7 | EUCTR2016-000196-24-DE (EUCTR) | 11/08/2016 | 27/06/2016 | BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Netherlands;Japan | ||
| 8 | EUCTR2016-000196-24-ES (EUCTR) | 04/07/2016 | 01/06/2016 | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION | A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Reata Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan | |||
| 9 | NCT02036970 (ClinicalTrials.gov) | May 2014 | 13/1/2014 | Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT | A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal Fibroelastosis | Drug: Bardoxolone methyl;Drug: Placebo | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 166 | Phase 2 | United States;Germany;Spain;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 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 |
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 |
| 6 | 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 |
| 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 | NCT03366337 (ClinicalTrials.gov) | December 26, 2017 | 4/12/2017 | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases | IgA Nephropathy;CKD Associated With Type 1 Diabetes;Focal Segmental Glomerulosclerosis;Autosomal Dominant Polycystic Kidney | Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 103 | Phase 2 | United States |