Diabetes Mellitus Type 2, Kidney Disease, Chronic Clinical Trial
Official title:
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE THE RISK OF END STAGE RENAL DISEASE AND CARDIOVASCULAR MORTALITY IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (ALERENAL STUDY)
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2019 |
| Est. primary completion date | January 2019 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death | Approximately 5 years | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality | Approximately 5 years | No |