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

Use our guide to learn which trials are right for you!

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
sites
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
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...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Arlington, Texas
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Azusa, California 91702
?
mi
from
Azusa, CA
Click here to add this to my saved trials
Baltimore, Maryland 21205
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beaumont, Texas 77702
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Bend, Oregon 97701
?
mi
from
Bend, OR
Click here to add this to my saved trials
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
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...
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Butte, MT
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45224
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Conyers, Georgia 30094
?
mi
from
Conyers, GA
Click here to add this to my saved trials
Corpus Christi, Texas 78404
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Corsicana, Texas 75110
?
mi
from
Corsicana, TX
Click here to add this to my saved trials
Council Bluffs, Iowa 51501
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
Crystal Lake, Illinois 60012
?
mi
from
Crystal Lake, IL
Click here to add this to my saved trials
?
mi
from
Debary, FL
Click here to add this to my saved trials
Deland, Florida 32720
?
mi
from
Deland, FL
Click here to add this to my saved trials
Edgewater, Florida 32132
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
El Centro, California 92243
?
mi
from
El Centro, CA
Click here to add this to my saved trials
415 East Yandell Drive
El Paso, Texas 79905
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Flint, Michigan 48532
?
mi
from
Flint, MI
Click here to add this to my saved trials
Flint, Michigan 48504
?
mi
from
Flint, MI
Click here to add this to my saved trials
Flushing, New York 11355
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Gonzales, Texas 78629
?
mi
from
Gonzales, TX
Click here to add this to my saved trials
Granada Hills, California 91344
?
mi
from
Granada Hills, CA
Click here to add this to my saved trials
Harrisburg, Arkansas 72432
?
mi
from
Harrisburg, AR
Click here to add this to my saved trials
Houston, Texas 77093
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77074
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77003
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77099
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77070
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35811
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Hutchinson, Kansas 67502
?
mi
from
Hutchinson, KS
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
Kansas City, Missouri 64128
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kissimmee, Florida 34741
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Kissimmee, Florida 34741
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Knoxville, Tennessee 37923
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lafayette, Louisiana 70503
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33311
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lomita, California 90717
?
mi
from
Lomita, CA
Click here to add this to my saved trials
Los Angeles, California 90022
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90020
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40213
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lynwood, California 90262
?
mi
from
Lynwood, CA
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marion, Ohio 43302
?
mi
from
Marion, OH
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33175
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33173
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53295
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Orleans, Louisiana 70115
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68131
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Omaha, Nebraska 68124
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32811
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Paducah, Kentucky 42003
?
mi
from
Paducah, KY
Click here to add this to my saved trials
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Pearland, Texas 77584
?
mi
from
Pearland, TX
Click here to add this to my saved trials
Peoria, Arizona 85381
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Prescott, Arizona 86301
?
mi
from
Prescott, AZ
Click here to add this to my saved trials
Riverside, California
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Rocky Mount, North Carolina 27804
?
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
Ruston, Louisiana 71270
?
mi
from
Ruston, LA
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78224
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
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...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Clarita, California 91350
?
mi
from
Santa Clarita, CA
Click here to add this to my saved trials
Shelby, North Carolina 28150
?
mi
from
Shelby, NC
Click here to add this to my saved trials
Shreveport, Louisiana 71101
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
St. Cloud, Florida 34769
?
mi
from
St. Cloud, FL
Click here to add this to my saved trials
Tempe, Arizona 85283
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Toney, Alabama 35773
?
mi
from
Toney, AL
Click here to add this to my saved trials
Troy, Michigan 48098
?
mi
from
Troy, MI
Click here to add this to my saved trials
Tucson, Arizona 85712
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Vancouver, British Columbia
?
mi
from
Vancouver,
Click here to add this to my saved trials
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
Whittier, California 90603
?
mi
from
Whittier, CA
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
Zachary, Louisiana 70791
?
mi
from
Zachary, LA
Click here to add this to my saved trials