A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)

Roche

Status and phase

Withdrawn

Phase 3

Conditions

Diabetes Mellitus Type 2, Kidney Disease, Chronic

Treatments

Drug: Aleglitazar

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01893242

BC28504

2013-000088-10 (EudraCT Number)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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