CompletedPhase 2

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

United States227 participantsStarted 2009-04-30

Plain-language summary

This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2 diabetes and chronic kidney disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patient, at least 18 years of age with known 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)
✓. The average of two eGFR values collected during screening must be within 20 - 45 mL/min/1.73m2, inclusive
✓. Patient must be receiving an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 3 months prior to screening, where the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, and has been stable and maintained on that dose for at least 8 weeks prior to the Randomization visit
✓. For male and female subjects, agreement 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, she must have a negative serum pregnancy test at screening and a negative urine pregnancy test confirmed within 72 hours prior to 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

✕. Type 1 (insulin-dependent; juvenile onset) diabetes, or any history of diabetic ketoacidosis
✕. Patients with known non-diabetic renal disease or patients with a history of a renal transplant
✕. Patients with a Hemoglobin A1c \>10% collected at the Screening A visit
✕. Cardiovascular disease as follows: Unstable angina pectoris within 3 months prior to study randomization; Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months prior to study randomization; Transient ischemic attack within 3 months of study randomization; Cerebrovascular accident within 3 months of study randomization; Obstructive valvular heart disease or hypertrophic cardiomyopathy; Diagnosis of Class III or IV congestive heart failure at any time
✕. Systolic blood pressure (BP) \>160 mmHg and diastolic blood pressure \> 90 determined by the average of three seated readings taken at least 5 minutes apart, at each of two time-points at least 5 days apart during the screening period
✕. QTc Fredericia interval \> 450 milliseconds determined by the average of values reported by a central reader from three ECGs taken at the Screening A visit. Each of the three ECGs will be obtained using only equipment provided by the Sponsor, and the ECGs shall be obtained at least ten minutes apart.
✕. Second or third degree atrioventricular block not successfully treated with a pacemaker
✕. Need for chronic (\>2 weeks) immunosuppressive therapy, or need for corticosteroids (excluding intraarticular injections,inhaled or nasal steroids) within 3 months of study randomization

What they're measuring

To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomization

Timeframe: 6 months (24 weeks)

To determine the safety and tolerability of bardoxolone methyl when administered for 12 months (52 weeks)following randomization to type 2 diabetic patients with CKD (eGFR 20 - 45 mL/min/1.73m2).

Timeframe: 1 year (52 weeks)

Trial details

NCT IDNCT00811889

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-05-31

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