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

Summary

This multicenter, randomized, double-blind, placebo-controlled Phase 2 safety study will assess the effect of bardoxolone methyl relative to placebo on body weight and fat mass in approximately 60 patients with stage 4 Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

Timeline

Start

2012-09-30

Primary completion

2012-10-31

Completion

2012-10-31

Outcome

Outcome not reported

Stopped: “IDMC recommendation for safety concerns”

Drugs

Indications