Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease

• Research type

  Research Study

• Full title

  Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON)

• IRAS ID

  83519

• Contact name

  Philip Kalra

• Sponsor organisation

  Reata Pharmaceuticals Inc

• Eudract number

  2010-022297-14

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The purpose of this study is to find out if bardoxolone methyl, an investigational drug being developed by Reata Pharmaceuticals, can help people with CKD and type 2 diabetes, when given in addition to standard of care treatment. This is a randomized, double-blind, placebo controlled trial, which means you will receive either bardoxolone methyl or placebo selected by chance. Double blind means that neither you, nor your study doctor and team, will know which study drug you will receive. The randomisation for this study means that you will have a 50% chance of receiving bardoxolone methyl and a 50% 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 patients with Stage 4 CKD and type 2 diabetes.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0690

• Date of REC Opinion

  7 Dec 2011

• REC opinion

  Further Information Favourable Opinion