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

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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus Type 2, Kidney Disease, Chronic
• Intervention / Treatment: Drug: Aleglitazar; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aleglitazar Arm	Drug: Aleglitazar; Aleglitazar 150 mcg oral doses, once a day for approximately 3 years
PLACEBO_COMPARATOR: Placebo Arm	Drug: Placebo; Matching placebo to aleglitazar, once a day for approximately 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (ESTIMATE): July 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: BC28504; 2013-000088-10 (EUDRACT_NUMBER)