16 completed, 9 terminated, 3 withdrawn. 12 Phase 1, 10 Phase 2, 7 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 12 | Completed 8, Terminated 3, Withdrawn 1 |
| Phase 2 | 10 | Completed 8, Withdrawn 2 |
| Phase 3 | 7 | Terminated 6, Completed 1 |
Follow bardoxolone methyl: new trials by email Literature Review of bardoxolone methyl trials Research Report on bardoxolone methyl
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN) Bardoxolone methyl oral capsule, Placebo oral capsule - Chronic Kidney Diseases | Phase 2 | Completed | Biogen | 81 | 2021-02-09 | 2025-06-03 |
| BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Bardoxolone Methyl, Placebo - Covid19 | Phase 2 | Completed | NYU Langone Health | 40 | 2020-09-08 | 2022-01-13 |
| A Study of RTA 402 in Obese Adults Bardoxolone methyl, Placebo - Obese Adult Male | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 22 | 2019-08-20 | 2020-06-23 |
| A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON Bardoxolone methyl oral capsule, Placebo oral capsule - Autosomal Dominant Polycystic Kidney, ADPKD | Phase 3 | Terminated | Biogen | 667 | 2019-05-29 | 2025-06-03 |
| A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults Bardoxolone methyl - Healthy Subject | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 36 | 2019-04-04 | 2020-02-05 |
| An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) Bardoxolone methyl - Chronic Kidney Diseases, Alport Syndrome | Phase 3 | Terminated | Biogen | 270 | 2019-03-08 | 2025-06-03 |
| A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study Bardoxolone methyl, Placebo - Diabetic Kidney Disease | Phase 3 | Terminated | Kyowa Kirin Co., Ltd. | 1323 | 2018-05-30 | 2023-09-26 |
| A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX Bardoxolone methyl capsules - IgA Nephropathy, CKD Associated With Type 1 Diabetes | Phase 2 | Completed | Biogen | 103 | 2017-12-26 | 2025-06-03 |
| Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults Bardoxolone methyl capsules 10 mg, Itraconazole capsules 100 mg - Healthy Volunteers | Phase 1 | Completed | Biogen | 16 | 2017-10-16 | 2025-05-29 |
| Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER Bardoxolone methyl - Pulmonary Hypertension | Phase 3 | Terminated | Biogen | 261 | 2017-04-18 | 2025-06-11 |
| A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL Placebo Oral Capsule, Bardoxolone Methyl - Alport Syndrome | Phase 2 / Phase 3 | Completed | Biogen | 187 | 2017-03-02 | 2025-06-11 |
| Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST Placebo capsules, Bardoxolone methyl capsules - Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Phase 3 | Terminated | Biogen | 202 | 2016-10-04 | 2025-06-04 |
| Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT Bardoxolone methyl, Placebo - Pulmonary Arterial Hypertension, Pulmonary Hypertension | Phase 2 | Completed | Biogen | 166 | 2014-05-31 | 2025-06-10 |
| A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus Bardoxolone Methyl, Placebo - Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | Phase 2 | Withdrawn | Biogen | 2012-09-30 | 2025-05-29 | |
| Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg, Bardoxolone Methyl Placebo - Healthy Volunteers | Phase 1 | Completed | Biogen | 179 | 2012-08-31 | 2025-05-29 |
| A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis Bardoxolone Methyl 20 mg, Placebo - End-Stage Renal Disease, Type 2 Diabetes Mellitus | Phase 2 | Withdrawn | Biogen | 2012-07-31 | 2025-05-29 | |
| Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function Bardoxolone Methyl - Hepatic Impairment, Healthy | Phase 1 | Completed | Biogen | 34 | 2012-04-30 | 2025-05-29 |
| Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes Bardoxolone Methyl - Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | Phase 1 | Terminated | Biogen | 24 | 2012-04-30 | 2025-05-29 |
| Pilot Assessment of the Effects of Bardoxolone Methyl on Renal Perfusion, Systemic Haemodynamics and Cardiac Function in Patients With Chronic Kidney Disease and Type 2 Diabetes Bardoxolone Methyl - Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | Phase 1 | Withdrawn | Biogen | 2012-04-30 | 2025-05-29 | |
| A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes 20 mg bardoxolone methyl, Placebo - Chronic Kidney Disease, Type 2 Diabetes | Phase 1 | Terminated | Biogen | 18 | 2012-01-31 | 2023-10-27 |
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Renal Insufficiency, Chronic (9) · Diabetes Mellitus, Type 2 (8) · Diabetic Nephropathies (5) · Hypertension, Pulmonary (3) · Polycystic Kidney, Autosomal Dominant (3) · Pulmonary Arterial Hypertension (3) · Nephritis, Hereditary (2) · Body Weight (1) · COVID-19 (1) · Cryptogenic Organizing Pneumonia (1) · Diabetes Mellitus (1) · Glomerulonephritis, IGA (1) · Glomerulosclerosis, Focal Segmental (1) · Hamman-Rich Syndrome (1) · Idiopathic Interstitial Pneumonias (1)
Biogen (24) · Kyowa Kirin Co., Ltd. (3) · NYU Langone Health (1)
United States (19) · Japan (8) · Australia (5) · Germany (5) · Spain (5) · United Kingdom (4) · Belgium (3) · Czechia (3) · France (3) · Argentina (2) · Brazil (2) · Canada (2) · Israel (2) · Mexico (2) · Netherlands (2)
Christine L Hale, MD (1) · Sripal Bangalore, MD, MHA (1)
PMID 33782940, PMID 37916745, PMID 21699484, PMID 24206459, PMID 33159213, PMID 33789284, PMID 36411058, PMID 39356039, PMID 40498549, PMID 41223909
2018 (1)