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

Primary Purpose

Diabetic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Selonsertib
Placebo to match selonsertib
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring Diabetic Kidney Disease, Gilead

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Alabama at Birmingham (UAB)
  • Chase Medcare
  • Choice Medicine
  • Akdhc Medical Research Services, Llc
  • Akdhc Medical Research Services, Llc
  • Akdhc Medical Research Services, Llc
  • Akdhc Medical Research Services, Llc
  • Robert J. Bloomberg, MD
  • AKDHC East Office
  • Clinical Research Connections, LLC
  • North America Research Institute
  • California Institute of Renal Research
  • California Institute of Renal Research Inc.
  • Renal Consultants Medical Group Granada Hills
  • Torrance Clinical Research
  • IMD Medical Group
  • Academic Medical Research Institute
  • Kidney Research Center
  • Apex Research of Riverside
  • San Francisco General Hospital
  • Clearview Medical Research, LLC
  • American Institute of Research
  • Omega Research Consultants
  • Creekside Medical Research
  • Riverside Clinical Research
  • ASA Clinical Research
  • FPA Clinical Research
  • The Chappel Group LLC
  • South Florida Research Institute
  • Prestige Clinical Research Center Inc
  • International Physicians Research / Nephrology Associates of South Miami
  • Tellus Clinical Research, Inc
  • Coral Research Clinic Corp
  • Suncoast Clinical Research, Inc.
  • Discovery Medical Research Group
  • Central Florida Internists
  • Sunset Point Medical Associates DBA
  • Pines Clinical Research Inc.
  • Central Florida Internists
  • Florida Pulmonary Research Institute
  • Rockdale Medical Research Associates
  • John H. Stroger Jr. Hospital Of Cook County
  • Midwest Endocrinology
  • Beacon Medical Group Kidney and Hypertension Center
  • West Broadway Clinic
  • Hutchinson Clinic, P.A
  • Kansas Nephrology Research Institute, LLC
  • L-MARC Research Center
  • Four Rivers Clinical Research
  • Research Nurse Specialists, LLc
  • Crescent City Clinical Research Center
  • Tulane University
  • Internal Medicine Specialists
  • Green Clinic LLC
  • Northwest Louisiana Nephrology
  • Southern Clinical Research
  • Johns Hopkins Hospital/University
  • A. Kaldun Nossuli MD Research
  • Wayne State University
  • Apex Medical Research.Com
  • Elite Clinical Research
  • Troy Internal Medicine, PC
  • VA Medical Center
  • Mercury Street Medical Group, PLLC, Big Sky Clinical Research, LLC
  • Alegent Creighton Health
  • Creighton Diabetes Center
  • Nephrology and Hypertension Associates of New Jersey
  • Albuquerque Clinical Trials
  • Nephrology Associates, PC
  • Mountain Kidney and Hypertension Associates
  • Boice-Willis Clinic
  • Carolina Research Center
  • Hightop Medical Research Center
  • Craig S Thompson MD LLC
  • Your Diabetes Endocrine Nutrition Group Inc
  • Chris Sholer, MD, PC
  • Bend Memorial Clinic
  • Southeast Renal Research Institute
  • Knoxville Kidney Center
  • Arlington Nephrology
  • MW Clinical Research Center
  • Padre Coast Clinical Research
  • Corsicana Medical Research, PLLC
  • Texas Tech Univ. Health Sciences Center
  • TVC Clinical Research
  • Diagnostic Clinic of Houston
  • Mercury Clinical Research
  • Lakewood Family Practice
  • Southwest Clinical Trials
  • Southwest Houston Research, Ltd.
  • HMRI CCAT Pearland
  • Clinical Advancement Center, PLLC
  • Briggs Clinical Research, LLC
  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
  • University of Texas Health Science Center at San Antonio
  • Val R. Hansen, M.D.
  • Fletcher Allen Health Care
  • University of Virginia
  • University of Wisconsin
  • Zablocki VAMC
  • BC Diabetes
  • Co-Medica Research Network
  • Clinical Research Solutions, Inc.
  • OTT Healthcare Inc.
  • Toronto East General Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Selonsertib 2 mg

Selonsertib 6 mg

Selonsertib 18 mg

Placebo to match selonsertib

Arm Description

Participants will receive selonsertib 2 mg for 48 weeks.

Participants will receive selonsertib 6 mg for 48 weeks.

Participants will receive selonsertib 18 mg for 48 weeks.

Participants will receive placebo to match selonsertib for 48 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
June 26, 2014
Last Updated
October 23, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02177786
Brief Title
Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
Diabetic Kidney Disease, Gilead

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selonsertib 2 mg
Arm Type
Experimental
Arm Description
Participants will receive selonsertib 2 mg for 48 weeks.
Arm Title
Selonsertib 6 mg
Arm Type
Experimental
Arm Description
Participants will receive selonsertib 6 mg for 48 weeks.
Arm Title
Selonsertib 18 mg
Arm Type
Experimental
Arm Description
Participants will receive selonsertib 18 mg for 48 weeks.
Arm Title
Placebo to match selonsertib
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to match selonsertib for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Selonsertib
Other Intervention Name(s)
GS-4997
Intervention Description
Tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match selonsertib
Intervention Description
Tablets administered orally once daily
Primary Outcome Measure Information:
Title
Change in eGFR From Baseline at Week 48
Description
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).
Time Frame
Baseline; Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48
Description
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.
Time Frame
Baseline; Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Chase Medcare
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35811
Country
United States
Facility Name
Choice Medicine
City
Toney
State/Province
Alabama
ZIP/Postal Code
35773
Country
United States
Facility Name
Akdhc Medical Research Services, Llc
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Akdhc Medical Research Services, Llc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Akdhc Medical Research Services, Llc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Akdhc Medical Research Services, Llc
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Robert J. Bloomberg, MD
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
AKDHC East Office
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Clinical Research Connections, LLC
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
North America Research Institute
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
California Institute of Renal Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
California Institute of Renal Research Inc.
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Renal Consultants Medical Group Granada Hills
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Torrance Clinical Research
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
IMD Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Kidney Research Center
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Clearview Medical Research, LLC
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91350
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Omega Research Consultants
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Creekside Medical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
ASA Clinical Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
The Chappel Group LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Prestige Clinical Research Center Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
International Physicians Research / Nephrology Associates of South Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Tellus Clinical Research, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Discovery Medical Research Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Central Florida Internists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32811
Country
United States
Facility Name
Sunset Point Medical Associates DBA
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Pines Clinical Research Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Central Florida Internists
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Florida Pulmonary Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Rockdale Medical Research Associates
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
John H. Stroger Jr. Hospital Of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Midwest Endocrinology
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Beacon Medical Group Kidney and Hypertension Center
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
West Broadway Clinic
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Hutchinson Clinic, P.A
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Kansas Nephrology Research Institute, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Research Nurse Specialists, LLc
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Crescent City Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Internal Medicine Specialists
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Green Clinic LLC
City
Ruston
State/Province
Louisiana
ZIP/Postal Code
71270
Country
United States
Facility Name
Northwest Louisiana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Southern Clinical Research
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Johns Hopkins Hospital/University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
A. Kaldun Nossuli MD Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Apex Medical Research.Com
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Elite Clinical Research
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Troy Internal Medicine, PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Mercury Street Medical Group, PLLC, Big Sky Clinical Research, LLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Alegent Creighton Health
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Nephrology and Hypertension Associates of New Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Nephrology Associates, PC
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Mountain Kidney and Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Boice-Willis Clinic
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Carolina Research Center
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Craig S Thompson MD LLC
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Your Diabetes Endocrine Nutrition Group Inc
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Chris Sholer, MD, PC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
Knoxville Kidney Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Arlington Nephrology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
MW Clinical Research Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Padre Coast Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Corsicana Medical Research, PLLC
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Texas Tech Univ. Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
TVC Clinical Research
City
Gonzales
State/Province
Texas
ZIP/Postal Code
78629
Country
United States
Facility Name
Diagnostic Clinic of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Mercury Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Lakewood Family Practice
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Southwest Houston Research, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
HMRI CCAT Pearland
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Briggs Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Val R. Hansen, M.D.
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States
Facility Name
Zablocki VAMC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
BC Diabetes
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
Co-Medica Research Network
City
Courtice
State/Province
Ontario
ZIP/Postal Code
L1E 3C3
Country
Canada
Facility Name
Clinical Research Solutions, Inc.
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2H 5Z8
Country
Canada
Facility Name
OTT Healthcare Inc.
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1H 3G4
Country
Canada
Facility Name
Toronto East General Medical Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31506292
Citation
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.
Results Reference
result
PubMed Identifier
26180085
Citation
Tesch 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.
Results Reference
derived

Learn more about this trial

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

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