Clinical trial NCT01893242: A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2, Kidney Disease, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
timeFrame: Approximately 5 years
measure: Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke)
timeFrame: Approximately 5 years
measure: Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality
timeFrame: Approximately 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: