Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
- Conditions
- Diabetic Kidney Disease
- Interventions
- Drug: Placebo to match selonsertib
- Registration Number
- NCT02177786
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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.
Trial Locations
- Locations (101)
Northwest Louisiana Nephrology
🇺🇸Shreveport, Louisiana, United States
Pines Clinical Research Inc.
🇺🇸Pembroke Pines, Florida, United States
Florida Pulmonary Research Institute
🇺🇸Winter Park, Florida, United States
Elite Clinical Research
🇺🇸Flint, Michigan, United States
Mercury Street Medical Group, PLLC, Big Sky Clinical Research, LLC
🇺🇸Butte, Montana, United States
North America Research Institute
🇺🇸Azusa, California, United States
Nephrology and Hypertension Associates of New Jersey
🇺🇸Voorhees, New Jersey, United States
American Institute of Research
🇺🇸Whittier, California, United States
AKDHC East Office
🇺🇸Tucson, Arizona, United States
Torrance Clinical Research
🇺🇸Lomita, California, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Mountain Kidney and Hypertension Associates
🇺🇸Asheville, North Carolina, United States
Clearview Medical Research, LLC
🇺🇸Santa Clarita, California, United States
Rockdale Medical Research Associates
🇺🇸Conyers, Georgia, United States
Kidney Research Center
🇺🇸Lynwood, California, United States
Akdhc Medical Research Services, Llc
🇺🇸Prescott, Arizona, United States
Renal Consultants Medical Group Granada Hills
🇺🇸Granada Hills, California, United States
Omega Research Consultants
🇺🇸DeBary, Florida, United States
Creekside Medical Research
🇺🇸DeLand, Florida, United States
Apex Research of Riverside
🇺🇸Riverside, California, United States
South Florida Research Institute
🇺🇸Lauderdale Lakes, Florida, United States
Hutchinson Clinic, P.A
🇺🇸Hutchinson, Kansas, United States
Internal Medicine Specialists
🇺🇸New Orleans, Louisiana, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
Apex Medical Research.Com
🇺🇸Flint, Michigan, United States
Midwest Endocrinology
🇺🇸Crystal Lake, Illinois, United States
Your Diabetes Endocrine Nutrition Group Inc
🇺🇸Mentor, Ohio, United States
MW Clinical Research Center
🇺🇸Beaumont, Texas, United States
Green Clinic LLC
🇺🇸Ruston, Louisiana, United States
Corsicana Medical Research, PLLC
🇺🇸Corsicana, Texas, United States
HMRI CCAT Pearland
🇺🇸Pearland, Texas, United States
Padre Coast Clinical Research
🇺🇸Corpus Christi, Texas, United States
Boice-Willis Clinic
🇺🇸Rocky Mount, North Carolina, United States
Central Florida Internists
🇺🇸Saint Cloud, Florida, United States
Sunset Point Medical Associates DBA
🇺🇸Palm Harbor, Florida, United States
Nephrology Associates, PC
🇺🇸Flushing, New York, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Arlington Nephrology
🇺🇸Arlington, Texas, United States
Carolina Research Center
🇺🇸Shelby, North Carolina, United States
Co-Medica Research Network
🇨🇦Courtice, Ontario, Canada
Val R. Hansen, M.D.
🇺🇸Bountiful, Utah, United States
Southeast Renal Research Institute
🇺🇸Chattanooga, Tennessee, United States
Knoxville Kidney Center
🇺🇸Knoxville, Tennessee, United States
Toronto East General Medical Centre
🇨🇦Toronto, Ontario, Canada
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Craig S Thompson MD LLC
🇺🇸Marion, Ohio, United States
OTT Healthcare Inc.
🇨🇦Scarborough, Ontario, Canada
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Clinical Research Solutions, Inc.
🇨🇦Kitchener, Ontario, Canada
IMD Medical Group
🇺🇸Los Angeles, California, United States
Academic Medical Research Institute
🇺🇸Los Angeles, California, United States
John H. Stroger Jr. Hospital Of Cook County
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hospital/University
🇺🇸Baltimore, Maryland, United States
Prestige Clinical Research Center Inc
🇺🇸Miami, Florida, United States
International Physicians Research / Nephrology Associates of South Miami
🇺🇸Miami, Florida, United States
Tellus Clinical Research, Inc
🇺🇸Miami, Florida, United States
Coral Research Clinic Corp
🇺🇸Miami, Florida, United States
Diagnostic Clinic of Houston
🇺🇸Houston, Texas, United States
Mercury Clinical Research
🇺🇸Houston, Texas, United States
Lakewood Family Practice
🇺🇸Houston, Texas, United States
Southwest Clinical Trials
🇺🇸Houston, Texas, United States
Southwest Houston Research, Ltd.
🇺🇸Houston, Texas, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
Briggs Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Chris Sholer, MD, PC
🇺🇸Oklahoma City, Oklahoma, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Choice Medicine
🇺🇸Toney, Alabama, United States
Robert J. Bloomberg, MD
🇺🇸Tempe, Arizona, United States
Chase Medcare
🇺🇸Huntsville, Alabama, United States
California Institute of Renal Research
🇺🇸Chula Vista, California, United States
Clinical Research Connections, LLC
🇺🇸Harrisburg, Arkansas, United States
California Institute of Renal Research Inc.
🇺🇸El Centro, California, United States
ASA Clinical Research
🇺🇸Jupiter, Florida, United States
FPA Clinical Research
🇺🇸Kissimmee, Florida, United States
The Chappel Group LLC
🇺🇸Kissimmee, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
West Broadway Clinic
🇺🇸Council Bluffs, Iowa, United States
Discovery Medical Research Group
🇺🇸Ocala, Florida, United States
Beacon Medical Group Kidney and Hypertension Center
🇺🇸Mishawaka, Indiana, United States
Kansas Nephrology Research Institute, LLC
🇺🇸Wichita, Kansas, United States
Research Nurse Specialists, LLc
🇺🇸Lafayette, Louisiana, United States
Crescent City Clinical Research Center
🇺🇸Metairie, Louisiana, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Southern Clinical Research
🇺🇸Zachary, Louisiana, United States
Troy Internal Medicine, PC
🇺🇸Troy, Michigan, United States
Texas Tech Univ. Health Sciences Center
🇺🇸El Paso, Texas, United States
TVC Clinical Research
🇺🇸Gonzales, Texas, United States
BC Diabetes
🇨🇦Vancouver, British Columbia, Canada
The University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
A. Kaldun Nossuli MD Research
🇺🇸Bethesda, Maryland, United States
VA Medical Center
🇺🇸Kansas City, Missouri, United States
Alegent Creighton Health
🇺🇸Omaha, Nebraska, United States
Creighton Diabetes Center
🇺🇸Omaha, Nebraska, United States
Zablocki VAMC
🇺🇸Milwaukee, Wisconsin, United States