At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 334 enrolled
Drug / intervention
Selonsertib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease
In Brief
A Phase 2 clinical trial evaluating Selonsertib and Placebo to match selonsertib for Diabetic Kidney Disease. Completed, enrolled 334 participants across 105 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Kidney Disease
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJun 2014
Primary CompletionJul 2016
Study CompletionAug 2016
TodayJul 2026
First PostedJun 30, 2014
Enrollment StartJun 1, 2014
Primary CompletionJul 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.0 years ago
Interventions
Selonsertibdrug
Tablets administered orally once daily
Placebo to match selonsertibdrug
Tablets administered orally once daily