A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease

Brief description of study

The study will examine if bardoxolone methyl, a drug being developed by Reata Pharmaceuticals, can improve autosomal dominant polycystic kidney disease (ADPKD), with its disease-modifying effects in kidney function. The goal is to assess the off treatment change from baseline in estimated glomerular filtration rate (eGFR) (a measure of kidney function) and to assess safety and tolerability. Bardoxolone methyl is an investigational (experimental) drug that is being tested, and is not approved by the U.S. Food and Drug Administration (FDA), or any other regulatory agency for sale in the United States or any other country. In this study, bardoxolone methyl,or placebo (pill with no chemical effect),will be given to participants as a capsule for 100 weeks. Be aware that this form refers to bardoxolone methyl as “study drug.”

Clinical Study Identifier: s20-01122
Principal Investigator: Naveed N. Masani.
Other Investigator: James Drakakis.

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