Study Of Diabetic Nephropathy With Atrasentan (SONAR)
|ClinicalTrials.gov Identifier: NCT01858532|
Recruitment Status : Terminated (Strategic considerations)
First Posted : May 21, 2013
Last Update Posted : April 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy||Drug: Atrasentan Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects With Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy With Atrasentan|
|Actual Study Start Date :||May 17, 2013|
|Actual Primary Completion Date :||March 29, 2018|
|Actual Study Completion Date :||March 29, 2018|
Active Comparator: Atrasentan
Subjects randomized to the atrasentan arm will receive active drug, atrasentan.
Oral daily low dose for 48 months.
Placebo Comparator: Placebo
Subjects randomized to the placebo arm will receive placebo.
Oral daily dosing for 48 months.
- Time to the first occurrence of a component of the composite renal endpoint. [ Time Frame: Approximately 48 months. ]Time to the first occurrence of a component of the composite renal endpoint: doubling of serum creatinine (confirmed by a 30-day serum creatinine) or the onset of end stage renal disease (estimated glomerular filtration rate (eGFR) less than 15 ml/min/1.73 m2 confirmed by a 90-day eGFR, receiving chronic dialysis, renal transplantation or renal death).
- Time to first occurrence of a component of composite renal endpoint: confirmed doubling of serum creatinine or the onset of end stage renal disease for all randomized subjects (pooled). [ Time Frame: Approximately 48 months. ]
- Time to a 50% estimated glomerular filtration rate reduction. [ Time Frame: Approximately 48 months. ]
- Time to the cardiovascular composite endpoint: cardiovascular death, nonfatal myocardial infarction and nonfatal stroke. [ Time Frame: Approximately 48 months. ]
- Time to cardio-renal composite endpoint: confirmed doubling of serum creatinine, end stage renal disease, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke. [ Time Frame: Approximately 48 months. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858532
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|Study Director:||AbbVie Inc.||AbbVie|