Conditions: Diabetic Kidney Disease
Keywords: Diabetic Kidney Disease Gilead
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 334
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants will receive selonsertib 2 mg for 48 weeks. arm 2: Participants will receive selonsertib 6 mg for 48 weeks. arm 3: Participants will receive selonsertib 18 mg for 48 weeks. arm 4: Participants will receive placebo to match selonsertib for 48 weeks.

Interventions: intervention 1: Selonsertib intervention 2: Placebo to match selonsertib
Intervention descriptions: intervention 1: Tablets administered orally once daily intervention 2: Tablets administered orally once daily

Protocol document: