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.
We found this trial at
101
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Marion, Ohio 43302
1982
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Marion, OH
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
1931
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Detroit, MI
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Pembroke Pines, Florida 33028
2713
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
1780
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San Antonio, TX
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Albuquerque, New Mexico
1184
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Albuquerque, NM
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Arlington, Texas
1670
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Arlington, TX
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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
1924
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Bend, Oregon 97701
249
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Bend, OR
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Bethesda, MD
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Birmingham, Alabama 35294
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Bountiful, Utah 84010
695
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
2325
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Burlington, VT
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476
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Butte, MT
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
2283
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Chattanooga, Tennessee 37404
2085
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Chattanooga, TN
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
1730
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Chicago, IL
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Chula Vista, California 91910
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Cincinnati, Ohio 45224
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Conyers, Georgia 30094
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Corpus Christi, Texas 78404
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Corsicana, Texas 75110
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Council Bluffs, Iowa 51501
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Crystal Lake, Illinois 60012
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Debary, FL
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Deland, Florida 32720
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Edgewater, Florida 32132
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El Centro, California 92243
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415 East Yandell Drive
El Paso, Texas 79905
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Flint, Michigan 48532
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Flint, Michigan 48504
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Flushing, New York 11355
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Gonzales, Texas 78629
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Granada Hills, California 91344
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Harrisburg, Arkansas 72432
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Houston, Texas 77093
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Houston, Texas 77074
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Houston, Texas 77003
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Houston, Texas 77099
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Houston, Texas 77070
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Huntsville, Alabama 35811
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Hutchinson, Kansas 67502
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Jupiter, Florida 33458
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Kansas City, Missouri 64128
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Kissimmee, Florida 34741
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Kissimmee, Florida 34741
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Knoxville, Tennessee 37923
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Lafayette, Louisiana 70503
2004
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Lauderdale Lakes, Florida 33311
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Lomita, California 90717
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Los Angeles, California 90022
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Los Angeles, California 90020
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Louisville, Kentucky 40213
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Lynwood, California 90262
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Metairie, Louisiana 70006
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Miami, Florida 33175
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Milwaukee, Wisconsin 53295
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New Orleans, Louisiana 70115
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New Port Richey, Florida 34652
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Ocala, Florida 34471
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Oklahoma City, Oklahoma 73116
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Omaha, Nebraska 68131
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Paducah, Kentucky 42003
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Palm Harbor, Florida 34684
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Pearland, Texas 77584
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Peoria, Arizona 85381
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Prescott, Arizona 86301
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Rocky Mount, North Carolina 27804
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Ruston, Louisiana 71270
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San Antonio, Texas 78224
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1001 Potrero Ave
San Francisco, California 94110
(415) 206-8000
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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Santa Clarita, California 91350
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Shelby, North Carolina 28150
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Shreveport, Louisiana 71101
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St. Cloud, Florida 34769
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Tempe, Arizona 85283
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Toney, Alabama 35773
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Troy, Michigan 48098
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Tucson, Arizona 85712
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Vancouver, British Columbia
119
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Whittier, California 90603
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Winter Park, Florida 32789
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Zachary, Louisiana 70791
2020
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