Study Of Diabetic Nephropathy With Atrasentan (SONAR)
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|ClinicalTrials.gov Identifier: NCT01858532|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Last Update Posted : March 12, 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|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||April 30, 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. ]
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 ClinicalTrials.gov identifier (NCT number): NCT01858532
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|Study Director:||AbbVie Inc.||AbbVie|