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

Inclusion criteria

• . Patients must have a history of type 2 diabetes; diagnosis of type 2 diabetes should have been made at \>30 years of age (if diabetes developed at a younger age, C-peptide level may be obtained to confirm diagnosis);
• . Patients must be at least 18 years of age;
• . The average of 2 eGFR values collected during screening must be within 15 - 45 mL /min/1.73m2 inclusive.
• . Patients must be receiving an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 8 weeks prior to screening, where the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, and the patient has been stable and maintained on that dose for at least 8 weeks prior to randomization (Day 1). No change in ACE or ARB therapy should be anticipated or planned for the period of the study.
• . Male and female patients must agree to use effective contraception during the entire study period and for at least 2 months after the last dose of study drug, unless documentation of infertility exists
• . Women of child-bearing potential must have a negative serum pregnancy test result at screening and a confirmed negative urine pregnancy test result prior to administration of the first dose of study medication;
• . Patient is willing and able to cooperate with all aspects of the protocol;
• . Patient is willing and able to give written informed consent for study participation

Exclusion criteria