Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes (NCT01351675) | Clinical Trial Compass
TerminatedPhase 3
Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes
Stopped: IDMC recommendation for safety concerns
2,185 participantsStarted 2011-06-30
Plain-language summary
This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Screening eGFR ≥ 15.0 and \< 30.0 mL/min/1.73 m2;
✓. A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age;
✓. Male or female at least 18 years of age;
✓. Treatment with an angiotensin converting enzyme (ACE)inhibitor and/or an angiotensin II receptor blocker (ARB)for at least 6 weeks prior to and during screening. Stable dose 2 weeks prior to and during screening. Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to Screening Visit A;
✓. Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be \< 90 mm Hg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within this range at two separate time points measured at least 4 days apart during the screening period (blood pressure may be re-evaluated once during an unscheduled visit);
✓. Willing to practice methods of birth control (both male and female patients) during the entire study period and for at least 30 days after the last dose of the study drug is ingested;
✓. Serum magnesium level must be ≥ 1.3 mEq/L (0.65 mmol/L) at Screening Visit B or during subsequent unscheduled visit during screening (serum magnesium level may be re-evaluated once during an unscheduled visit);
✓. Willing and able to cooperate with all aspects of the protocol;
Exclusion criteria
✕. Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a C-peptide level must confirm type 2 diabetes;
✕. Known non-diabetic renal disease (e.g., polycystic kidney disease, focal segmental glomerulosclerosis) \[nephrosclerosis superimposed on diabetic kidney disease is acceptable\];
✕. Ongoing clinical evidence suggesting non-diabetic renal disease other than nephrosclerosis;
✕. History of a renal transplant or a planned transplant from a living donor during the study;
✕. Albumin to creatinine ratio (ACR) greater than 3500 mg/g (395.5 mg/mmol);
✕. Hemoglobin A1c level \> 11.0% (97 mmol/mol) during screening;
✕. Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening;
✕. Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following randomization, as assessed by the investigator;