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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:1/14/2017
Start Date:June 2014
End Date:August 2016

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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

This study will evaluate the efficacy, safety, and tolerability of selonsertib (formerly
GS-4997) 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.


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 < 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 o 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

- 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

- Anticipated progression to ESRD (need for dialysis or listing for renal
transplantation) within the study treatment period

- Unstable cardiovascular disease

- Immunosuppressive drugs

- Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Albuquerque, New Mexico
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
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Pembroke Pines, Florida 33028
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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Arlington, Texas
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Asheville, North Carolina 28801
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Azusa, California 91702
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Baltimore, Maryland 21205
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Beaumont, Texas 77702
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Bend, Oregon 97701
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Bountiful, Utah 84010
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
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Charlottesville, Virginia 22903
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Chattanooga, Tennessee 37404
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1969 W Ogden Ave
Chicago, Illinois 60612
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Chula Vista, California 91910
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