A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)
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ClinicalTrials.gov Identifier: NCT01893242 |
Recruitment Status
:
Withdrawn
First Posted
: July 8, 2013
Last Update Posted
: November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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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 |
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 |
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Change History | Complete list of historical versions of study NCT01893242 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Diabetes Mellitus Type 2, Kidney Disease, Chronic | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
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 ) |
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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 |
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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 |