Effects of Bardoxolone Methyl on Residual Renal Function in PD
Research type
Research Study
Full title
A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Bardoxolone Methyl on Residual Renal Function in Patients with End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis
IRAS ID
103796
Contact name
Simon Davies
Sponsor organisation
Reata UK Limited
Eudract number
2012-001563-78
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to assess the safety and effect on residual renal function of bardoxolone methyl, an investigational drug, being developed by Reata Pharmaceuticals, to placebo in individuals with end-stage renal disease and type 2 diabetics undergoing perotineal dialysis. This study is a multi-center, double-blind, randomized, placebo-controlled safety study. This means that you will receive either bardoxolone methyl or placebo by chance. Double blind means that neither you, nor your study doctor and team, will know which study drug you will receive. Patients will be randomized to receive the study drug or placebo on a 2:1 allocation. This means that you will have a 2/3 chance of receiving bardoxolone methyl and a 1/3 chance of receiving placebo. Placebo is a capsule that looks like bardoxolone methyl but does not contain any active ingredients, much like a sugar pill. Bardoxolone methyl is an investigational (experimental) drug that is being tested in treating CKD. The purpose of this study is to compare the efficacy (how well the drug works) and safety of oral (given by mouth) bardoxolone methyl to placebo in type 2 diabetic patients who are on perotineal dialysis.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
12/LO/0815
Date of REC Opinion
3 Jul 2012
REC opinion
Further Information Favourable Opinion