Trials / Completed
CompletedNCT02177786
Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 334 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selonsertib | Tablets administered orally once daily |
| DRUG | Placebo to match selonsertib | Tablets administered orally once daily |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2016-07-01
- Completion
- 2016-08-01
- First posted
- 2014-06-30
- Last updated
- 2019-11-05
- Results posted
- 2019-06-11
Locations
105 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02177786. Inclusion in this directory is not an endorsement.