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

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177786
• Other study ID #: GS-US-223-1015
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

• 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.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Selonsertib
Tablets administered orally once daily
• Placebo to match selonsertib
Tablets administered orally once daily

Locations

Country	Name	City	State
Canada	Co-Medica Research Network	Courtice	Ontario
Canada	Clinical Research Solutions, Inc.	Kitchener	Ontario
Canada	OTT Healthcare Inc.	Scarborough	Ontario
Canada	Toronto East General Medical Centre	Toronto	Ontario
Canada	BC Diabetes	Vancouver	British Columbia
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Arlington Nephrology	Arlington	Texas
United States	Mountain Kidney and Hypertension Associates	Asheville	North Carolina
United States	North America Research Institute	Azusa	California
United States	Johns Hopkins Hospital/University	Baltimore	Maryland
United States	MW Clinical Research Center	Beaumont	Texas
United States	Bend Memorial Clinic	Bend	Oregon
United States	A. Kaldun Nossuli MD Research	Bethesda	Maryland
United States	The University of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Val R. Hansen, M.D.	Bountiful	Utah
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Mercury Street Medical Group, PLLC, Big Sky Clinical Research, LLC	Butte	Montana
United States	University of Virginia	Charlottesville	Virginia
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	John H. Stroger Jr. Hospital Of Cook County	Chicago	Illinois
United States	California Institute of Renal Research	Chula Vista	California
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	Rockdale Medical Research Associates	Conyers	Georgia
United States	Padre Coast Clinical Research	Corpus Christi	Texas
United States	Corsicana Medical Research, PLLC	Corsicana	Texas
United States	West Broadway Clinic	Council Bluffs	Iowa
United States	Midwest Endocrinology	Crystal Lake	Illinois
United States	Omega Research Consultants	DeBary	Florida
United States	Creekside Medical Research	DeLand	Florida
United States	Wayne State University	Detroit	Michigan
United States	Riverside Clinical Research	Edgewater	Florida
United States	California Institute of Renal Research Inc.	El Centro	California
United States	Texas Tech Univ. Health Sciences Center	El Paso	Texas
United States	Apex Medical Research.Com	Flint	Michigan
United States	Elite Clinical Research	Flint	Michigan
United States	Nephrology Associates, PC	Flushing	New York
United States	TVC Clinical Research	Gonzales	Texas
United States	Renal Consultants Medical Group Granada Hills	Granada Hills	California
United States	Clinical Research Connections, LLC	Harrisburg	Arkansas
United States	Diagnostic Clinic of Houston	Houston	Texas
United States	Lakewood Family Practice	Houston	Texas
United States	Mercury Clinical Research	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	Southwest Houston Research, Ltd.	Houston	Texas
United States	Chase Medcare	Huntsville	Alabama
United States	Hutchinson Clinic, P.A	Hutchinson	Kansas
United States	ASA Clinical Research	Jupiter	Florida
United States	VA Medical Center	Kansas City	Missouri
United States	FPA Clinical Research	Kissimmee	Florida
United States	The Chappel Group LLC	Kissimmee	Florida
United States	Knoxville Kidney Center	Knoxville	Tennessee
United States	Research Nurse Specialists, LLc	Lafayette	Louisiana
United States	South Florida Research Institute	Lauderdale Lakes	Florida
United States	Torrance Clinical Research	Lomita	California
United States	Academic Medical Research Institute	Los Angeles	California
United States	IMD Medical Group	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Kidney Research Center	Lynwood	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Craig S Thompson MD LLC	Marion	Ohio
United States	Your Diabetes Endocrine Nutrition Group Inc	Mentor	Ohio
United States	Crescent City Clinical Research Center	Metairie	Louisiana
United States	Coral Research Clinic Corp	Miami	Florida
United States	International Physicians Research / Nephrology Associates of South Miami	Miami	Florida
United States	Prestige Clinical Research Center Inc	Miami	Florida
United States	Tellus Clinical Research, Inc	Miami	Florida
United States	Zablocki VAMC	Milwaukee	Wisconsin
United States	Beacon Medical Group Kidney and Hypertension Center	Mishawaka	Indiana
United States	Internal Medicine Specialists	New Orleans	Louisiana
United States	Tulane University	New Orleans	Louisiana
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Discovery Medical Research Group	Ocala	Florida
United States	Chris Sholer, MD, PC	Oklahoma City	Oklahoma
United States	Alegent Creighton Health	Omaha	Nebraska
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Central Florida Internists	Orlando	Florida
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Sunset Point Medical Associates DBA	Palm Harbor	Florida
United States	HMRI CCAT Pearland	Pearland	Texas
United States	Pines Clinical Research Inc.	Pembroke Pines	Florida
United States	Akdhc Medical Research Services, Llc	Peoria	Arizona
United States	Akdhc Medical Research Services, Llc	Phoenix	Arizona
United States	Akdhc Medical Research Services, Llc	Phoenix	Arizona
United States	Akdhc Medical Research Services, Llc	Prescott	Arizona
United States	Apex Research of Riverside	Riverside	California
United States	Boice-Willis Clinic	Rocky Mount	North Carolina
United States	Green Clinic LLC	Ruston	Louisiana
United States	Central Florida Internists	Saint Cloud	Florida
United States	Briggs Clinical Research, LLC	San Antonio	Texas
United States	Clinical Advancement Center, PLLC	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	San Francisco General Hospital	San Francisco	California
United States	Clearview Medical Research, LLC	Santa Clarita	California
United States	Carolina Research Center	Shelby	North Carolina
United States	Northwest Louisiana Nephrology	Shreveport	Louisiana
United States	Robert J. Bloomberg, MD	Tempe	Arizona
United States	Choice Medicine	Toney	Alabama
United States	Troy Internal Medicine, PC	Troy	Michigan
United States	AKDHC East Office	Tucson	Arizona
United States	Nephrology and Hypertension Associates of New Jersey	Voorhees	New Jersey
United States	American Institute of Research	Whittier	California
United States	Kansas Nephrology Research Institute, LLC	Wichita	Kansas
United States	Florida Pulmonary Research Institute	Winter Park	Florida
United States	Southern Clinical Research	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).	Baseline; Week 48
Secondary	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 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.	Baseline; Week 48