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
1 other identifier
interventional
334
2 countries
105
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 26, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
June 11, 2019
CompletedNovember 5, 2019
October 1, 2019
2.1 years
June 26, 2014
May 23, 2019
October 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in eGFR From Baseline at Week 48
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 Ă— age\^-0.203 Ă— 1.212 (if participant is black) Ă— 0.742 (if female).
Baseline; Week 48
Secondary Outcomes (1)
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
Study Arms (4)
Selonsertib 2 mg
EXPERIMENTALParticipants will receive selonsertib 2 mg for 48 weeks.
Selonsertib 6 mg
EXPERIMENTALParticipants will receive selonsertib 6 mg for 48 weeks.
Selonsertib 18 mg
EXPERIMENTALParticipants will receive selonsertib 18 mg for 48 weeks.
Placebo to match selonsertib
PLACEBO COMPARATORParticipants will receive placebo to match selonsertib for 48 weeks.
Interventions
Tablets administered orally once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (105)
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294, United States
Chase Medcare
Huntsville, Alabama, 35811, United States
Choice Medicine
Toney, Alabama, 35773, United States
Akdhc Medical Research Services, Llc
Peoria, Arizona, 85381, United States
Akdhc Medical Research Services, Llc
Phoenix, Arizona, 85012, United States
Akdhc Medical Research Services, Llc
Phoenix, Arizona, 85027, United States
Akdhc Medical Research Services, Llc
Prescott, Arizona, 86301, United States
Robert J. Bloomberg, MD
Tempe, Arizona, 85283, United States
AKDHC East Office
Tucson, Arizona, 85712, United States
Clinical Research Connections, LLC
Harrisburg, Arkansas, 72432, United States
North America Research Institute
Azusa, California, 91702, United States
California Institute of Renal Research
Chula Vista, California, 91910, United States
California Institute of Renal Research Inc.
El Centro, California, 92243, United States
Renal Consultants Medical Group Granada Hills
Granada Hills, California, 91344, United States
Torrance Clinical Research
Lomita, California, 90717, United States
IMD Medical Group
Los Angeles, California, 90020, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Kidney Research Center
Lynwood, California, 90262, United States
Apex Research of Riverside
Riverside, California, 92505, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
Clearview Medical Research, LLC
Santa Clarita, California, 91350, United States
American Institute of Research
Whittier, California, 90603, United States
Omega Research Consultants
DeBary, Florida, 32713, United States
Creekside Medical Research
DeLand, Florida, 32720, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
ASA Clinical Research
Jupiter, Florida, 33458, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
The Chappel Group LLC
Kissimmee, Florida, 34741, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
Prestige Clinical Research Center Inc
Miami, Florida, 33133, United States
International Physicians Research / Nephrology Associates of South Miami
Miami, Florida, 33173, United States
Tellus Clinical Research, Inc
Miami, Florida, 33173, United States
Coral Research Clinic Corp
Miami, Florida, 33175, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Discovery Medical Research Group
Ocala, Florida, 34471, United States
Central Florida Internists
Orlando, Florida, 32811, United States
Sunset Point Medical Associates DBA
Palm Harbor, Florida, 34684, United States
Pines Clinical Research Inc.
Pembroke Pines, Florida, 33028, United States
Central Florida Internists
Saint Cloud, Florida, 34769, United States
Florida Pulmonary Research Institute
Winter Park, Florida, 32789, United States
Rockdale Medical Research Associates
Conyers, Georgia, 30094, United States
John H. Stroger Jr. Hospital Of Cook County
Chicago, Illinois, 60612, United States
Midwest Endocrinology
Crystal Lake, Illinois, 60012, United States
Beacon Medical Group Kidney and Hypertension Center
Mishawaka, Indiana, 46544, United States
West Broadway Clinic
Council Bluffs, Iowa, 51501, United States
Hutchinson Clinic, P.A
Hutchinson, Kansas, 67502, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Research Nurse Specialists, LLc
Lafayette, Louisiana, 70503, United States
Crescent City Clinical Research Center
Metairie, Louisiana, 70006, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Internal Medicine Specialists
New Orleans, Louisiana, 70115, United States
Green Clinic LLC
Ruston, Louisiana, 71270, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
Southern Clinical Research
Zachary, Louisiana, 70791, United States
Johns Hopkins Hospital/University
Baltimore, Maryland, 21205, United States
A. Kaldun Nossuli MD Research
Bethesda, Maryland, 20814, United States
Wayne State University
Detroit, Michigan, 48201, United States
Apex Medical Research.Com
Flint, Michigan, 48504, United States
Elite Clinical Research
Flint, Michigan, 48532, United States
Troy Internal Medicine, PC
Troy, Michigan, 48098, United States
VA Medical Center
Kansas City, Missouri, 64128, United States
Mercury Street Medical Group, PLLC, Big Sky Clinical Research, LLC
Butte, Montana, 59701, United States
Alegent Creighton Health
Omaha, Nebraska, 68131, United States
Creighton Diabetes Center
Omaha, Nebraska, 68131, United States
Nephrology and Hypertension Associates of New Jersey
Voorhees Township, New Jersey, 08043, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Nephrology Associates, PC
Flushing, New York, 11355, United States
Mountain Kidney and Hypertension Associates
Asheville, North Carolina, 28801, United States
Boice-Willis Clinic
Rocky Mount, North Carolina, 27804, United States
Carolina Research Center
Shelby, North Carolina, 28150, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45231, United States
Craig S Thompson MD LLC
Marion, Ohio, 43302, United States
Your Diabetes Endocrine Nutrition Group Inc
Mentor, Ohio, 44060, United States
Chris Sholer, MD, PC
Oklahoma City, Oklahoma, 73116, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408, United States
Knoxville Kidney Center
Knoxville, Tennessee, 37923, United States
Arlington Nephrology
Arlington, Texas, 76015, United States
MW Clinical Research Center
Beaumont, Texas, 77701, United States
Padre Coast Clinical Research
Corpus Christi, Texas, 78404, United States
Corsicana Medical Research, PLLC
Corsicana, Texas, 75110, United States
Texas Tech Univ. Health Sciences Center
El Paso, Texas, 79905, United States
TVC Clinical Research
Gonzales, Texas, 78629, United States
Diagnostic Clinic of Houston
Houston, Texas, 77004, United States
Mercury Clinical Research
Houston, Texas, 77036, United States
Lakewood Family Practice
Houston, Texas, 77070, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Southwest Houston Research, Ltd.
Houston, Texas, 77099, United States
HMRI CCAT Pearland
Pearland, Texas, 77584, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215, United States
Briggs Clinical Research, LLC
San Antonio, Texas, 78224, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Val R. Hansen, M.D.
Bountiful, Utah, 84010, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Wisconsin
Madison, Wisconsin, 53713, United States
Zablocki VAMC
Milwaukee, Wisconsin, 53295, United States
BC Diabetes
Vancouver, British Columbia, V5Z1M9, Canada
Co-Medica Research Network
Courtice, Ontario, L1E 3C3, Canada
Clinical Research Solutions, Inc.
Kitchener, Ontario, N2H 5Z8, Canada
OTT Healthcare Inc.
Scarborough Village, Ontario, M1H 3G4, Canada
Toronto East General Medical Centre
Toronto, Ontario, Canada
Related Publications (2)
Chertow GM, Pergola PE, Chen F, Kirby BJ, Sundy JS, Patel UD; GS-US-223-1015 Investigators. Effects of Selonsertib in Patients with Diabetic Kidney Disease. J Am Soc Nephrol. 2019 Oct;30(10):1980-1990. doi: 10.1681/ASN.2018121231. Epub 2019 Sep 10.
PMID: 31506292RESULTTesch GH, Ma FY, Han Y, Liles JT, Breckenridge DG, Nikolic-Paterson DJ. ASK1 Inhibitor Halts Progression of Diabetic Nephropathy in Nos3-Deficient Mice. Diabetes. 2015 Nov;64(11):3903-13. doi: 10.2337/db15-0384. Epub 2015 Jul 15.
PMID: 26180085DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2014
First Posted
June 30, 2014
Study Start
June 1, 2014
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
November 5, 2019
Results First Posted
June 11, 2019
Record last verified: 2019-10