A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
Phase 3
Withdrawn
- Conditions
- Diabetes Mellitus Type 2, Kidney Disease, Chronic
- Interventions
- Drug: Placebo
- Registration Number
- NCT01893242
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult patients >= 18 years of age at screening
- Diagnosis of diabetes mellitus Type 2
- Glycosylated hemoglobin A1C (HbA1C) < 10% at screening
- Estimated glomerular filtration rate (eGFR) >=30 and < 60 mL/min/1.73 m2
- Urinary albumin-to-creatinine ratio (UACR) >=500 and < 5000 mg/g
- Treatment with either angiotensin converting enzyme inhibitor or angiotensin II receptor blocker for at least three months prior to screening
- Women of child-bearing potential using a highly effective birth control method must be willing to use the same method of contraception during the entire course of the study
Exclusion Criteria
- Treatment with a PPARgamma agonist and/or PPARalpha agonist in the last 12 weeks screening
- Prior intolerance to a TDZ or fibrate
- Previous participation in a trial with aleglitazar
- Diagnosis or history of other types of diabetes
- Diagnosis or history of acute metabolic diabetic complications within the past 6 months
- Known primary glomerulonephritis, secondary glomerulonephritis other than diabetic nephropathy or polycystic kidney disease
- Diagnosed acute kidney injury or dialysis within 12 weeks prior to screening
- Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at baseline)
- Known secondary hypertension due to renal artery stenosis, primary aldosteronism, or pheochromocytoma
- History of myocardial infarction or stroke in the past 12 weeks prior to screening
- Symptomatic congestive heart failure NYHA class II-IV at baseline or heart failure leading to hospitalization within the 12 months prior to screening
- Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
- Inadequate liver and hematological function
- Chronic treatment with immunosuppressive therapy
- Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective birth control methods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aleglitazar Arm Aleglitazar - Placebo Arm Placebo -
- Primary Outcome Measures
Name Time Method Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death Approximately 5 years
- Secondary Outcome Measures
Name Time Method Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) Approximately 5 years Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke) Approximately 5 years Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality Approximately 5 years