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This study has been withdrawn prior to enrollment.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: July 7, 2014
Last verified: July 2014
  Purpose

This randomized, double-blind, placebo-controlled study will evaluate the potent ial of aleglitazar to reduce the risk of end stage renal disease and cardiovascu lar mortality in patients with type 2 diabetes mellitus and chronic kidney disea se. Patients will be randomized to receive oral daily doses of aleglitazar or ma tching placebo. The anticipated time on study treatment is approximately 3 years


Condition Intervention Phase
Diabetes Mellitus, Type 2, Kidney Disease, Chronic
Drug: Aleglitazar
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: December 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893242

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01893242     History of Changes
Other Study ID Numbers: BC28504, 2013-000088-10
Study First Received: July 2, 2013
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 29, 2014