Clinical trial NCT00664027 (phase 2, status: completed)
Conditions: diabetic nephropathy
ICD codes: E10.21, E11.21, E13.21, E08.21, E09.21
Drugs: rta 402 (bardoxolone methyl)
SMILES: COC(=O)[C@]12CCC(C)(C)C[C@H]1[C@H]1C(=O)C=C3[C@@]4(C)C=C(C#N)C(=O)C(C)(C)[C@@H]4CC[C@@]3(C)[C@]1(C)CC2
Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of type 2 diabetes;

          2. Serum creatinine in women 1.3 - 3.0 mg/dL (115-265 μmol/L), inclusive, and in men 1.5
             - 3.0 mg/dL (133-265 μmol/L), inclusive;

          3. Patient must agree to practice effective contraception.

          4. Patient must have a negative urine pregnancy test within 72 hours prior to the first
             dose of study medication.

          5. Patient is willing and able to cooperate with all aspects of the protocol and is able
             to communicate effectively.

          6. Patient is willing and able to provide written informed consent to participate in this
             clinical study.

        Exclusion Criteria:

          1. Type 1 (insulin-dependent; juvenile onset) diabetes.

          2. Patients with known non-diabetic renal disease (nephrosclerosis superimposed on
             diabetic nephropathy acceptable), or with renal allograft.

          3. Cardiovascular disease as follows: unstable angina pectoris within 3 mo of study
             entry; myocardial infarction, coronary artery bypass graft surgery, or percutaneous
             transluminal coronary angioplasty/stent within 3 mo of study entry; transient ischemic
             attack within 3 mo of study entry; cerebrovascular accident within 3 mo of study
             entry; obstructive valvular heart disease or hypertrophic cardiomyopathy; second or
             third degree atrioventricular block not successfully treated with a pacemaker.

          4. Need for chronic (>2 weeks) immunosuppressive therapy, including corticosteroids
             (excluding inhaled or nasal steroids) within 3 mo of study entry.

          5. Evidence of hepatic dysfunction including total bilirubin >1.5 mg/dL (>26
             micromole/L); elevation of liver transaminase (aspartate aminotransferase [AST] or
             alanine transferase [ALT])above the upper limit of normal(ULN) within the 14-day
             screening period; documented elevation (above ULN) of AST or ALT within 3 months prior
             to screening; elevation of alkaline phosphatase (ALP) above 1.5 x ULN; documented
             elevation of gamma-glutamyl transpeptidase (GGT) above 1.5 X ULN.

          6. If female, patient is pregnant, nursing or planning a pregnancy.

          7. Patient has any concurrent clinical conditions that in the judgment of the
             investigator could either potentially pose a health risk to the patient while involved
             in the study or could potentially influence the study outcome;

          8. Patient has known hypersensitivity to any component of the study drug;

          9. Patient has known allergy to iodine;

         10. Patient has undergone diagnostic or intervention procedure requiring a contrast agent
             within the last 30 days prior to entry into the study;

         11. Change or dose-adjustment in any of the following medications: ACE inhibitors,
             angiotensin II blockers, non-steroidal anti inflammatory drugs (NSAIDs), or COX-2
             inhibitors within 3 months; other anti-hypertensive, and other anti-diabetic
             medications within 6 weeks prior to entry into the study;

         12. Patient has a history of drug or alcohol abuse or has positive test results for any
             drug of abuse (positive urine drug test and/or alcohol breathalyzer test).

         13. Patients who are unable or unwilling to discontinue the following medications until 1
             week following last dose of study treatment: Nicotinic acid, Isoniazid, Dantrolene,
             Labetalol, Pemoline, Felbamate, Zileutan, Tolcapone, Trovafloxacin, Vitamin D, Vitamin
             D analogues (such as Calcitriol, paricalcitol, doxercalciferol), or multivitamins
             containing vitamin D or related analogs, or Fenofibrate. Patient must have been off
             the aforementioned medications for a minimum of two weeks prior to enrollment.

         14. Patient with an intact parathyroid hormone (iPTH) level > 300 pg/mL.

         15. Patient has participated in another clinical study involving investigational or
             marketed products within 30 days prior to entry into the study or would concomitantly
             participate in such a study.

         16. Patient is unable to communicate or cooperate with the Investigator due to language
             problems, poor mental development or impaired cerebral function.