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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01893242
Recruitment Status : Withdrawn
First Posted : July 8, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death [ Time Frame: Approximately 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01893242

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

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Responsible Party: Hoffmann-La Roche Identifier: NCT01893242     History of Changes
Other Study ID Numbers: BC28504
2013-000088-10 ( EudraCT Number )
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency