Phase 2
N=384
Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
Diabetic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT04026165 ↗Enrolled (actual)
384
Serious AEs
15.9%
Results posted
Dec 2022
Primary outcome: Primary: Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr) — 32.7; 34.9 mL/min/1.73m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SEL (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr) |
32.7; 34.9 | — |
| PRIMARY eGFRcr Slope |
-2.29; -3.49 | 0.1439 |
| SECONDARY Percentage of Participants With Kidney Clinical Events at Week 48 |
9.1; 9.0 | 0.8353 |
| SECONDARY Time From Randomization to First Occurrence of a Kidney Clinical Event: Event Rate Per 100 Participant-years for First Occurrence of Kidney Clinical Event |
13.4; 9.8 | 0.2010 |
| SECONDARY Pre-run-in Baseline Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys) |
33.6; 32.4 | — |
| SECONDARY eGFRcys Slope |
-3.79; -4.23 | 0.5399 |
Summary
The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines.
- Estimated glomerular filtration rate (eGFR) value calculated by central laboratory utilizing samples collected during screening and prior to enrollment of ≥ 20 mL/min/1.73 m^2 to 12.0% within 30 days prior to enrollment
- Individuals with diagnosis of type 1 diabetes mellitus (T1DM) or maturity onset diabetes of the young (MODY)
- Body mass index (BMI) > 50 kg/m^2
- UACR > 5000 mg/g on any measurement during screening
- End stage kidney disease (ESKD) (i.e., chronic hemodialysis, chronic peritoneal dialysis, or history of kidney transplantation)
- Anticipated progression to ESKD (need for chronic hemodialysis, chronic peritoneal dialysis or receipt of kidney transplant) within 3 months after enrollment
- Unstable cardiovascular disease
- Pregnant or lactating females or planning to become pregnant or breastfeed during the study
- Concurrent use of either
- ACEi and ARB or
- Mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to Enrollment
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04026165). 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.