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

Tracking Information
First Submitted Date ICMJE	July 2, 2013
First Posted Date ICMJE	July 8, 2013
Last Update Posted Date	November 2, 2016
Study Start Date ICMJE	December 2013
Estimated Primary Completion Date	January 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 9, 2013)	Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death [ Time Frame: Approximately 5 years ]
Original Primary Outcome Measures ICMJE; (submitted: July 5, 2013)	Occurrence of end stage renal disease [ Time Frame: Approximately 5 years ]; Occurrence of cardivascular disease [ Time Frame: Approximately 5 years ]
Change History	Complete list of historical versions of study NCT01893242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 9, 2013)	Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) [ Time Frame: 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) [ Time Frame: Approximately 5 years ]; Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality [ Time Frame: Approximately 5 years ]
Original Secondary Outcome Measures ICMJE; (submitted: July 5, 2013)	Time to the first occurrence of major adverse cardiovascular event [ Time Frame: Approximately 5 years ]; Time to the first occurrence of macrovascular event [ Time Frame: Approximately 5 years ]; Safety: Incidence of adverse events [ Time Frame: Approximately 5 years ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
Official Title ICMJE	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)
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus Type 2, Kidney Disease, Chronic
Intervention ICMJE	Drug: Aleglitazar Aleglitazar 150 mcg oral doses, once a day for approximately 3 years; Drug: Placebo Matching placebo to aleglitazar, once a day for approximately 3 years
Study Arms	Experimental: Aleglitazar Arm Intervention: Drug: Aleglitazar; Placebo Comparator: Placebo Arm Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: July 23, 2013)	0
Original Estimated Enrollment ICMJE; (submitted: July 5, 2013)	5200
Estimated Study Completion Date	January 2019
Estimated Primary Completion Date	January 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01893242
Other Study ID Numbers ICMJE	BC28504; 2013-000088-10 ( EudraCT Number )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hoffmann-La Roche
Study Sponsor ICMJE	Hoffmann-La Roche
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Clinical Trials Hoffmann-La Roche
PRS Account	Hoffmann-La Roche
Verification Date	November 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP