Phase 2
N=334
Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
Diabetic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02177786 ↗Enrolled (actual)
334
Serious AEs
24.0%
Results posted
Jun 2019
Primary outcome: Primary: Change in eGFR From Baseline at Week 48 — -2.83; -2.37; -4.07; -3.20 mL/min/1.73 m^2 — p=0.755
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Selonsertib (Drug); Placebo to match selonsertib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in eGFR From Baseline at Week 48 |
-2.83; -2.37; -4.07; -3.20 | 0.755 |
| SECONDARY Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48 |
28.4; 21.4; 27.7; 30.6 | 0.798 |
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.
Eligibility Criteria
Key Inclusion Criteria
- Adult male or females with prior diagnosis of Diabetic Kidney Disease
- Type 2 diabetes mellitus diagnosis for at least 6 months
- eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to 9.5%
- Non-diabetic kidney disease
- UACR > 5000 mg/g on any measurement during screening
- End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status post renal transplantation) or anticipated to occur within the treatment period
- Unstable cardiovascular disease
- Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02177786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.