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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01893242
First received: July 2, 2013
Last updated: April 7, 2014
Last verified: April 2014

July 2, 2013
April 7, 2014
December 2013
January 2019   (final data collection date for primary outcome measure)
Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Occurrence of end stage renal disease [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Occurrence of cardivascular disease [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01893242 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to the first occurrence of major adverse cardiovascular event [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Time to the first occurrence of macrovascular event [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2, Kidney Disease, Chronic
  • 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
  • Experimental: Aleglitazar Arm
    Intervention: Drug: Aleglitazar
  • Placebo Comparator: Placebo Arm
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2019
January 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01893242
BC28504, 2013-000088-10
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP