Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

Phase 2

Completed

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.

Recruitment & Eligibility

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 < 60 mL/min/1.73m^2
Urine albumin to creatinine ratio (UACR) as follows:
- Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g
- Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g
- Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g
Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months
- Individuals not on ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or ARB

Key

Exclusion Criteria

Type 1 diabetes mellitus
HbA1c > 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.

Arm && Interventions

Group	Intervention	Description
Selonsertib 2 mg	Selonsertib	Participants will receive selonsertib 2 mg for 48 weeks.
Selonsertib 6 mg	Selonsertib	Participants will receive selonsertib 6 mg for 48 weeks.
Selonsertib 18 mg	Selonsertib	Participants will receive selonsertib 18 mg for 48 weeks.
Placebo to match selonsertib	Placebo to match selonsertib	Participants will receive placebo to match selonsertib for 48 weeks.

Primary Outcome Measures

Name	Time	Method
Change in eGFR From Baseline at Week 48	Baseline; Week 48	The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 × age\^-0.203 × 1.212 (if participant is black) × 0.742 (if female).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48	Baseline; Week 48	Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.

Locations (101): The University of Alabama at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States
Chase Medcare
🇺🇸
Huntsville, Alabama, United States
Choice Medicine
🇺🇸
Toney, Alabama, United States
Akdhc Medical Research Services, Llc
🇺🇸
Prescott, Arizona, United States
Robert J. Bloomberg, MD
🇺🇸
Tempe, Arizona, United States
AKDHC East Office
🇺🇸
Tucson, Arizona, United States
Clinical Research Connections, LLC
🇺🇸
Harrisburg, Arkansas, United States
North America Research Institute
🇺🇸
Azusa, California, United States
California Institute of Renal Research
🇺🇸
Chula Vista, California, United States
California Institute of Renal Research Inc.
🇺🇸
El Centro, California, United States
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The University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States