MedPath

Bardoxolone

Generic Name
Bardoxolone
Drug Type
Small Molecule
Chemical Formula
C31H41NO4
CAS Number
218600-44-3
Unique Ingredient Identifier
7HT68L8941
Background

Bardoxolone has been used in trials studying the treatment of LYMPHOMA and Solid Tumors. It is a synthetic triterpenoid and a highly potent activator of redox-sensitive signaling pathways that induce programmed cell death (apoptosis) in cancer cells that are under high levels of intrinsic oxidative stress. In contrast, Bardoxolone in normal cells induces protective antioxidant/anti-inflammatory responses.

Indication

用于治疗亚伯氏症(遗传性肾炎)导致的慢性肾病(CKD)。

A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)

Phase 2
Completed
Conditions
Chronic Kidney Diseases
Interventions
Drug: Placebo oral capsule
First Posted Date
2021-01-11
Last Posted Date
2024-02-05
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
81
Registration Number
NCT04702997
Locations
🇺🇸

California Institute of Renal Research, La Mesa, California, United States

🇺🇸

Renal Associates of Baton Rouge, Baton Rouge, Louisiana, United States

🇺🇸

Columbia Nephrology Associates, PA, Columbia, South Carolina, United States

and more 8 locations

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON

Phase 3
Terminated
Conditions
ADPKD
Autosomal Dominant Polycystic Kidney
Interventions
Drug: Placebo oral capsule
First Posted Date
2019-04-17
Last Posted Date
2024-06-11
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
667
Registration Number
NCT03918447
Locations
🇺🇸

Florida Premier Research Institute, LLC, Winter Park, Florida, United States

🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

and more 131 locations

A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX

Phase 2
Completed
Conditions
Autosomal Dominant Polycystic Kidney
IgA Nephropathy
CKD Associated With Type 1 Diabetes
Focal Segmental Glomerulosclerosis
Interventions
First Posted Date
2017-12-08
Last Posted Date
2024-02-05
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
103
Registration Number
NCT03366337
Locations
🇺🇸

Tufts Medical Center - Division of Nephrology Tufts Medical Center, Boston, Massachusetts, United States

🇺🇸

Gulfcoast Endocrine and Diabetes Center, Clearwater, Florida, United States

🇺🇸

Advanced Clinical Research, West Jordan, Utah, United States

and more 26 locations

Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2017-08-28
Last Posted Date
2024-02-02
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
16
Registration Number
NCT03264079
Locations
🇺🇸

Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, United States

Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

Phase 3
Terminated
Conditions
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Interventions
Drug: Placebo capsules
First Posted Date
2016-01-15
Last Posted Date
2024-02-06
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
202
Registration Number
NCT02657356
Locations
🇺🇸

Wexner Medical Center at The Ohio State University, Columbus, Ohio, United States

🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

🇺🇸

Boston University School of Medicine, Boston, Massachusetts, United States

and more 103 locations

Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers

First Posted Date
2012-09-21
Last Posted Date
2024-02-02
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
179
Registration Number
NCT01689116
Locations
🇺🇸

Spaulding Clinical Research, LLC, West Bend, Wisconsin, United States

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

Phase 2
Withdrawn
Conditions
Type 2 Diabetes Mellitus
End-Stage Renal Disease
Interventions
First Posted Date
2012-04-13
Last Posted Date
2024-02-02
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Registration Number
NCT01576887

Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes

Phase 3
Terminated
Conditions
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo
First Posted Date
2011-05-11
Last Posted Date
2024-02-02
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
2185
Registration Number
NCT01351675

Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease

Phase 2
Completed
Conditions
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-01-22
Last Posted Date
2024-02-02
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
129
Registration Number
NCT01053936

Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease

Phase 2
Completed
Conditions
Chronic Kidney Disease
Type 2 Diabetes
Diabetic Nephropathy
Interventions
First Posted Date
2008-12-19
Last Posted Date
2024-02-02
Lead Sponsor
Reata, a wholly owned subsidiary of Biogen
Target Recruit Count
227
Registration Number
NCT00811889
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