The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
334
Tablets administered orally once daily
Tablets administered orally once daily
Change in eGFR From Baseline at Week 48
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 × age\^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
Time frame: Baseline; Week 48
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48
Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.
Time frame: Baseline; Week 48
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The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Chase Medcare
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Toney, Alabama, United States
Akdhc Medical Research Services, Llc
Peoria, Arizona, United States
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Akdhc Medical Research Services, Llc
Phoenix, Arizona, United States
Akdhc Medical Research Services, Llc
Prescott, Arizona, United States
Robert J. Bloomberg, MD
Tempe, Arizona, United States
AKDHC East Office
Tucson, Arizona, United States
Clinical Research Connections, LLC
Harrisburg, Arkansas, United States
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