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Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease (MOSAIC)

Primary Purpose

Diabetic Kidney Disease

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

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines.

  • Estimated glomerular filtration rate (eGFR) value calculated by central laboratory utilizing samples collected during screening and prior to enrollment of ≥ 20 mL/min/1.73 m^2 to < 60 mL/min/1.73 m^2 with albuminuria

    • eGFR and urine albumin to creatinine ratio (UACR) must meet criteria a, b, or c

      • a: eGFR (mL/min/1.73 m^2): ≥ 45 to < 60; UACR (mg/g): ≥ 600 to 5000
      • b: eGFR (mL/min/1.73 m^2): ≥ 30 to < 45; UACR (mg/g): ≥ 300 to 5000
      • c: eGFR (mL/min/1.73 m^2): ≥ 20 to < 30; UACR (mg/g): ≥ 150 to 5000

  • Treatment with either an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)

    • Individuals not receiving an ACEi or ARB may be enrolled if there is documented intolerance to ACEi and ARB
    • Individuals receiving less-than-maximal dose of an ACEi or ARB may be enrolled if there is a documented reason that the maximum labeled dose of ACEi and ARB could not be reached
  • Individuals already receiving sodium-glucose co-transporter-2 (SGLT-2) inhibitors must be on a stable dose for at least 2 weeks prior to enrollment
  • Mean systolic blood pressure (SBP) must be <160 mmHg and mean diastolic blood pressure (DBP) must be <100 mmHg
  • Required baseline laboratory data, analyzed by central laboratory, within 30 days prior to enrollment

Key Exclusion Criteria:

  • Hemoglobin A1c (HbA1c) > 12.0% within 30 days prior to enrollment
  • Individuals with diagnosis of type 1 diabetes mellitus (T1DM) or maturity onset diabetes of the young (MODY)
  • Body mass index (BMI) > 50 kg/m^2
  • UACR > 5000 mg/g on any measurement during screening
  • End stage kidney disease (ESKD) (i.e., chronic hemodialysis, chronic peritoneal dialysis, or history of kidney transplantation)
  • Anticipated progression to ESKD (need for chronic hemodialysis, chronic peritoneal dialysis or receipt of kidney transplant) within 3 months after enrollment
  • Unstable cardiovascular disease
  • Pregnant or lactating females or planning to become pregnant or breastfeed during the study

  • Concurrent use of either

    1. ACEi and ARB or
    2. Mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to Enrollment
  • Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Arizona Kidney Disease and Hypertension Centers
  • AKDHC Medical Research Services, LLC
  • Clearview Medical Research, LLC
  • Kidney Disease Medical Group, Inc.
  • Renal Consultants Medical Group
  • Marin Endocrine Care & Research, Inc.
  • California Institute of Renal Research
  • Academic Medical Research Institute
  • Rose Salter Medical Research Foundation
  • Valley Renal Medical Group Research
  • California Institute of Renal Research
  • California Kidney Specialist
  • Creekside Endocrine Associates, PC
  • New West Physicians, Inc
  • Western Nephrology and Metabolic Bone Disease, PC
  • Omega Research Maitland, LLC
  • South Florida Research Institute
  • Suncoast Clinical Research, Inc.
  • Discovery Medical Research Group, Inc
  • Coastal Nephrology Associates Research Center, LLC. D/B/A Volunteer Medical Research
  • Atlanta Center for Clinical Research
  • Georgia Nephrology Research Institute
  • East-West Medical Research Institute
  • Boise Kidney & Hypertension, PLLC
  • Research By Design, LLC
  • Buynak Clinical Research, P.C.
  • West Broadway Clinic
  • Kansas Nephrology Research Institute, LLC
  • Four Rivers Clinical Research
  • Internal Medicine Specialists, Inc
  • Northwest Louisiana Nephrology L.L.C
  • Aa Mrc, Llc
  • Elite Research Center
  • Arcturus Healthcare, PLC, Troy Internal Medicine Research Division
  • Clinical Research Consultants, LLC
  • Pelican Point Dialysis - DaVita Clinical Research
  • Albany Medical College
  • CHEAR Center LLC
  • North Shore University Hospital: Division of Nephrology
  • Endocrine Associates of Long Island, PC
  • Mountain Kidney and Hypertension Associates
  • Mountain Diabetes & Endocrine Center
  • Carteret Medical Group
  • Diabetes And Endocrinology Consultants, P.C.
  • PMG Research of Rocky Mount, LLC
  • PMG Research Inc., d/b/a PMG Research of Piedmont Healthcare
  • Wilmington Health, PLLC
  • PMG Research of Winston-Salem, LLC
  • SV Research LLC
  • Midwest Nephrology Group, PLLC
  • Heritage Valley Medical Group, Inc.
  • Northeast Clinical Research Center, LLC
  • Lifespan Clinical Research Center
  • PMG Research Of Charleston, LLC
  • Southeast Renal Research Institute
  • University Diabetes and Endocrine Consultants
  • PMG Research, Inc d/b/a/ PMG Research of Knoxville
  • Knoxville Kidney Center, PLLC
  • PMG Research, Inc. d/b/a PMG Research of Knoxville
  • Memphis Veteran Affairs Medical Center
  • Arlington Nephrology
  • Corsicana Medical Research, LLC
  • North Texas Endocrine Center
  • The Medical Group of Texas
  • Primecare Medical Group
  • DaVita Clinical Research
  • Mercury Clinical Research
  • DaVita Clinical Research
  • Houston Methodist Research Institute - CCAT Pearland
  • Northeast Clinical Research of San Antonio
  • Clinical Advancement Center, PLLC
  • Austin Health and University of Melbourne
  • St. Vincent Hospital, Melbourne
  • Royal Melbourne Hospital
  • LMC Clinical Research Inc. (Barrie)
  • LMC Clinical Research Inc. (Brampton)
  • LMC Clinical research Inc. (Thornhill)
  • LMC Clinical Research Inc. (Etobicoke)
  • Clinical Research Solution Inc.
  • Centre de Recherche Clinique de Lava
  • Dr TGElliott Inc dba BC Diabetes
  • Winnipeg Clinic
  • Asahikawa Medical University Hospital
  • National Hospital Organization Chiba-East-Hospital
  • Kagoshima University Hospital
  • Kokura Memorial Hospital
  • Yamanashi Prefectural Central Hospital
  • Kurobe City Hospital
  • Kurume University Hospital
  • Nakamoto Medical Clinic
  • Kozawa Eye Hospital and Diabetes Center
  • Japanese Red Cross Musashino Hospital
  • Nagasaki University Hospital
  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
  • Daido Clinic
  • Nakakinen Clinic
  • Niigata University Medical & Dental Hospital
  • Okayama University Hospital
  • Osaka General Medical Center
  • Hoshina Clinic
  • Sanuki Municipal Hospital
  • Tachikawa Hospital
  • Mishuku Hospital
  • Nihon University Itabashi Hospital
  • TOYOTA Memorial Hospital
  • Yokohama City University Hospital
  • Auckland City Hospital (Auckland District Health Board)
  • Middlemore Clinical Trials Trust trading as Middlemore Clinical Trials
  • Lipid and Diabetes Research Group
  • Waitemata District Health Board- North Shore Hospital
  • Endocrine, Diabetes & Research Centre (Capital and Coast District Health Board)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Selonsertib

Placebo

Arm Description

Run-in Period (5 Weeks): Participants will receive placebo-to-match SEL for at least one week and then SEL 18 mg for at least 4 weeks. Randomized Period: Participants will be randomized to receive SEL 18 mg for at least 48 weeks.

Run-in Period (5 Weeks): Participants will receive placebo-to-match SEL for at least one week and then SEL 18 mg for at least 4 weeks. Randomized Period: Participants will be randomized to receive placebo-to-match SEL for at least 48 weeks.

Outcomes

Primary Outcome Measures

Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr)
The values of eGFRcr were calculated using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation (2009). eGFRcr = 141*min(Standardized Serum Creatinine (Scr)/kappa, 1) ^alpha*max(Scr/ kappa, 1)^(-1.209)*0.993^Age*1.018[if female]*1.159[if Black], where kappa=0.7(females) or 0.9(males), alpha=-0.329(females) or -0.411(males). min indicates the minimum of Scr/kappa or 1, max indicates the maximum of Scr/kappa or 1, and age is in years. Treatment-specific Baselines = the average of Visits A and B values for Placebo, and the average of Visit C and Day 1 values for SEL. Visit A= enrollment, Visit B= 7-14 days after Visit A, Visit C= 21-28 days after Visit B, and Visit 1= 7-14 days after Visit C.
eGFRcr Slope
The values of eGFRcr were calculated using the CKD-EPI Creatinine Equation (2009). eGFRcr = 141*min(Scr/kappa, 1) ^alpha*max(Scr/kappa, 1)^(-1.209)*0.993^Age*1.018[if female]*1.159[if Black], where kappa=0.7(females) or 0.9(males), alpha=-0.329(females) or -0.411(males). min indicates the minimum of Scr/kappa or 1, max indicates the maximum of Scr/kappa or 1, and age is in years. Treatment specific baselines for eGFRcr: average of Visit A (enrollment) and Visit B (7-14 days after Visit A) values for Placebo, and average of Visit C (21-28 days after Visit B, and Visit 1 (7-14 days after Visit C) values for SEL.

Secondary Outcome Measures

Percentage of Participants With Kidney Clinical Events at Week 48
Kidney clinical events were defined as any of the following events: confirmed ≥ 40% decline in eGFRcr from baseline, or kidney failure (dialysis performed for at least 4 weeks, kidney transplantation, or confirmed decrease in eGFRcr to < 15 mL/min/1.73 m^2 for participants without dialysis or kidney transplantation), or death due to kidney disease.
Time From Randomization to First Occurrence of a Kidney Clinical Event: Event Rate Per 100 Participant-years for First Occurrence of Kidney Clinical Event
Kidney clinical events were defined as any of the following events: confirmed ≥ 40% decline in eGFRcr from baseline, or kidney failure (dialysis performed for at least 4 weeks, kidney transplantation, or confirmed decrease in eGFRcr to < 15 mL/min/1.73 m^2 for participants without dialysis or kidney transplantation), or death due to kidney disease. This outcome measure was analyzed using event rate per 100 participant-years for first occurrence of kidney clinical event. Participant year was calculated as total follow-up duration across all participants in a given group. Follow-up duration was defined as time from Randomization to the earliest of study completion, premature study discontinuation, death, or event of interest in each row.
Pre-run-in Baseline Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys)
eGFRcys = Estimated Glomerular Filtration Rate calculated by CKD-EPI Cystatin C Equation (2012). eGFR = 133*min(Standardized Serum Cystatin (Scys)/0.8, 1) ^(-0.499)*max(Scys/0.8, 1)^(-1.328)*0.996^Age*0.932[if female]. min indicates the minimum of Scys/0.8 or 1, max indicates the maximum of Scr/0.8 or 1, and age is in years.
eGFRcys Slope
eGFRcys = Estimated Glomerular Filtration Rate calculated by CKD-EPI Cystatin C Equation (2012). eGFR = 133*min(Scys/0.8, 1) ^(-0.499)*max(Scys/0.8, 1)^(-1.328)*0.996^Age*0.932[if female]. min indicates the minimum of Scys/0.8 or 1, max indicates the maximum of Scr/0.8 or 1, and age is in years. Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values.

Full Information

First Posted
July 17, 2019
Last Updated
November 29, 2022
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04026165
Brief Title
Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
Acronym
MOSAIC
Official Title
MOSAIC - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects With Moderate to Advanced Diabetic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 3, 2021 (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 evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).
Detailed Description
Following the screening period, eligible participants will enroll into a Run-in period of at least 5 weeks and receive placebo to match SEL for at least 1 week and then SEL for at least 4 weeks. After completing Run-in period, eligible participants will be randomized and receive either SEL or placebo to match SEL for at least 48 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Participants received Run-in and Randomized treatments sequentially and in the Randomized Phase, the treatments were assigned in parallel.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selonsertib
Arm Type
Experimental
Arm Description
Run-in Period (5 Weeks): Participants will receive placebo-to-match SEL for at least one week and then SEL 18 mg for at least 4 weeks. Randomized Period: Participants will be randomized to receive SEL 18 mg for at least 48 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Run-in Period (5 Weeks): Participants will receive placebo-to-match SEL for at least one week and then SEL 18 mg for at least 4 weeks. Randomized Period: Participants will be randomized to receive placebo-to-match SEL for at least 48 weeks.
Intervention Type
Drug
Intervention Name(s)
SEL
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet administered orally once daily
Primary Outcome Measure Information:
Title
Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr)
Description
The values of eGFRcr were calculated using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation (2009). eGFRcr = 141*min(Standardized Serum Creatinine (Scr)/kappa, 1) ^alpha*max(Scr/ kappa, 1)^(-1.209)*0.993^Age*1.018[if female]*1.159[if Black], where kappa=0.7(females) or 0.9(males), alpha=-0.329(females) or -0.411(males). min indicates the minimum of Scr/kappa or 1, max indicates the maximum of Scr/kappa or 1, and age is in years. Treatment-specific Baselines = the average of Visits A and B values for Placebo, and the average of Visit C and Day 1 values for SEL. Visit A= enrollment, Visit B= 7-14 days after Visit A, Visit C= 21-28 days after Visit B, and Visit 1= 7-14 days after Visit C.
Time Frame
Treatment-specific Baselines (From enrollment (Visit A) up to 14 days after Visit A for placebo and from Visit C up to 14 days after Visit C for SEL)
Title
eGFRcr Slope
Description
The values of eGFRcr were calculated using the CKD-EPI Creatinine Equation (2009). eGFRcr = 141*min(Scr/kappa, 1) ^alpha*max(Scr/kappa, 1)^(-1.209)*0.993^Age*1.018[if female]*1.159[if Black], where kappa=0.7(females) or 0.9(males), alpha=-0.329(females) or -0.411(males). min indicates the minimum of Scr/kappa or 1, max indicates the maximum of Scr/kappa or 1, and age is in years. Treatment specific baselines for eGFRcr: average of Visit A (enrollment) and Visit B (7-14 days after Visit A) values for Placebo, and average of Visit C (21-28 days after Visit B, and Visit 1 (7-14 days after Visit C) values for SEL.
Time Frame
Treatment-specific Baselines through Week 84
Secondary Outcome Measure Information:
Title
Percentage of Participants With Kidney Clinical Events at Week 48
Description
Kidney clinical events were defined as any of the following events: confirmed ≥ 40% decline in eGFRcr from baseline, or kidney failure (dialysis performed for at least 4 weeks, kidney transplantation, or confirmed decrease in eGFRcr to < 15 mL/min/1.73 m^2 for participants without dialysis or kidney transplantation), or death due to kidney disease.
Time Frame
Week 48
Title
Time From Randomization to First Occurrence of a Kidney Clinical Event: Event Rate Per 100 Participant-years for First Occurrence of Kidney Clinical Event
Description
Kidney clinical events were defined as any of the following events: confirmed ≥ 40% decline in eGFRcr from baseline, or kidney failure (dialysis performed for at least 4 weeks, kidney transplantation, or confirmed decrease in eGFRcr to < 15 mL/min/1.73 m^2 for participants without dialysis or kidney transplantation), or death due to kidney disease. This outcome measure was analyzed using event rate per 100 participant-years for first occurrence of kidney clinical event. Participant year was calculated as total follow-up duration across all participants in a given group. Follow-up duration was defined as time from Randomization to the earliest of study completion, premature study discontinuation, death, or event of interest in each row.
Time Frame
From randomization up to Week 101
Title
Pre-run-in Baseline Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys)
Description
eGFRcys = Estimated Glomerular Filtration Rate calculated by CKD-EPI Cystatin C Equation (2012). eGFR = 133*min(Standardized Serum Cystatin (Scys)/0.8, 1) ^(-0.499)*max(Scys/0.8, 1)^(-1.328)*0.996^Age*0.932[if female]. min indicates the minimum of Scys/0.8 or 1, max indicates the maximum of Scr/0.8 or 1, and age is in years.
Time Frame
Pre-run-in Baseline (Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values)
Title
eGFRcys Slope
Description
eGFRcys = Estimated Glomerular Filtration Rate calculated by CKD-EPI Cystatin C Equation (2012). eGFR = 133*min(Scys/0.8, 1) ^(-0.499)*max(Scys/0.8, 1)^(-1.328)*0.996^Age*0.932[if female]. min indicates the minimum of Scys/0.8 or 1, max indicates the maximum of Scr/0.8 or 1, and age is in years. Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values.
Time Frame
Pre-run-in Baseline through Week 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines. Estimated glomerular filtration rate (eGFR) value calculated by central laboratory utilizing samples collected during screening and prior to enrollment of ≥ 20 mL/min/1.73 m^2 to < 60 mL/min/1.73 m^2 with albuminuria eGFR and urine albumin to creatinine ratio (UACR) must meet criteria a, b, or c a: eGFR (mL/min/1.73 m^2): ≥ 45 to < 60; UACR (mg/g): ≥ 600 to 5000 b: eGFR (mL/min/1.73 m^2): ≥ 30 to < 45; UACR (mg/g): ≥ 300 to 5000 c: eGFR (mL/min/1.73 m^2): ≥ 20 to < 30; UACR (mg/g): ≥ 150 to 5000 Treatment with either an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) Individuals not receiving an ACEi or ARB may be enrolled if there is documented intolerance to ACEi and ARB Individuals receiving less-than-maximal dose of an ACEi or ARB may be enrolled if there is a documented reason that the maximum labeled dose of ACEi and ARB could not be reached Individuals already receiving sodium-glucose co-transporter-2 (SGLT-2) inhibitors must be on a stable dose for at least 2 weeks prior to enrollment Mean systolic blood pressure (SBP) must be <160 mmHg and mean diastolic blood pressure (DBP) must be <100 mmHg Required baseline laboratory data, analyzed by central laboratory, within 30 days prior to enrollment Key Exclusion Criteria: Hemoglobin A1c (HbA1c) > 12.0% within 30 days prior to enrollment Individuals with diagnosis of type 1 diabetes mellitus (T1DM) or maturity onset diabetes of the young (MODY) Body mass index (BMI) > 50 kg/m^2 UACR > 5000 mg/g on any measurement during screening End stage kidney disease (ESKD) (i.e., chronic hemodialysis, chronic peritoneal dialysis, or history of kidney transplantation) Anticipated progression to ESKD (need for chronic hemodialysis, chronic peritoneal dialysis or receipt of kidney transplant) within 3 months after enrollment Unstable cardiovascular disease Pregnant or lactating females or planning to become pregnant or breastfeed during the study Concurrent use of either ACEi and ARB or Mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to Enrollment Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results 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
Arizona Kidney Disease and Hypertension Centers
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
AKDHC Medical Research Services, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Clearview Medical Research, LLC
City
Canyon Country
State/Province
California
ZIP/Postal Code
91350
Country
United States
Facility Name
Kidney Disease Medical Group, Inc.
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Renal Consultants Medical Group
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Marin Endocrine Care & Research, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
California Institute of Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942-3059
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Rose Salter Medical Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Valley Renal Medical Group Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Kidney Specialist
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Creekside Endocrine Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
New West Physicians, Inc
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Western Nephrology and Metabolic Bone Disease, PC
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Omega Research Maitland, LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
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, Inc
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Coastal Nephrology Associates Research Center, LLC. D/B/A Volunteer Medical Research
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Atlanta Center for Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Georgia Nephrology Research Institute
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Boise Kidney & Hypertension, PLLC
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research By Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
Buynak Clinical Research, P.C.
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
West Broadway Clinic
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Kansas Nephrology Research Institute, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Internal Medicine Specialists, Inc
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Northwest Louisiana Nephrology L.L.C
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Aa Mrc, Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Elite Research Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Arcturus Healthcare, PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Pelican Point Dialysis - DaVita Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
CHEAR Center LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
North Shore University Hospital: Division of Nephrology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Endocrine Associates of Long Island, PC
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
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
Mountain Diabetes & Endocrine Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Carteret Medical Group
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Diabetes And Endocrinology Consultants, P.C.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research of Rocky Mount, LLC
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
PMG Research Inc., d/b/a PMG Research of Piedmont Healthcare
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Wilmington Health, PLLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
SV Research LLC
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Midwest Nephrology Group, PLLC
City
Midwest City
State/Province
Oklahoma
ZIP/Postal Code
73130
Country
United States
Facility Name
Heritage Valley Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Lifespan Clinical Research Center
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
PMG Research Of Charleston, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
University Diabetes and Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
PMG Research, Inc d/b/a/ PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Knoxville Kidney Center, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
PMG Research, Inc. d/b/a PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Memphis Veteran Affairs Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Arlington Nephrology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Corsicana Medical Research, LLC
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The Medical Group of Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76116
Country
United States
Facility Name
Primecare Medical Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
DaVita Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mercury Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
DaVita Clinical Research
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Houston Methodist Research Institute - CCAT Pearland
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Northeast Clinical Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78154
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Austin Health and University of Melbourne
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
St. Vincent Hospital, Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
LMC Clinical Research Inc. (Barrie)
City
Barrie
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
LMC Clinical Research Inc. (Brampton)
City
Brampton
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
LMC Clinical research Inc. (Thornhill)
City
Concord
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
LMC Clinical Research Inc. (Etobicoke)
City
Etobicoke
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Clinical Research Solution Inc.
City
Kitchener
ZIP/Postal Code
N2H 5Z8
Country
Canada
Facility Name
Centre de Recherche Clinique de Lava
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Dr TGElliott Inc dba BC Diabetes
City
Vancouver
ZIP/Postal Code
V5Y 3W2
Country
Canada
Facility Name
Winnipeg Clinic
City
Winnipeg
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Asahikawa Medical University Hospital
City
Asahikawa
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
National Hospital Organization Chiba-East-Hospital
City
Chiba
ZIP/Postal Code
260-0801
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu-shi
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
ZIP/Postal Code
400-0027
Country
Japan
Facility Name
Kurobe City Hospital
City
Kurobe-shi
ZIP/Postal Code
938-8502
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Nakamoto Medical Clinic
City
Mito-shi
ZIP/Postal Code
310-0826
Country
Japan
Facility Name
Kozawa Eye Hospital and Diabetes Center
City
Mito-shi
ZIP/Postal Code
310-0845
Country
Japan
Facility Name
Japanese Red Cross Musashino Hospital
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
City
Nagoya-shi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Daido Clinic
City
Nagoya-shi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Nakakinen Clinic
City
Naka-shi
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
9518520
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Hoshina Clinic
City
Saitama-shi
ZIP/Postal Code
338-0837
Country
Japan
Facility Name
Sanuki Municipal Hospital
City
Sanuki-shi
ZIP/Postal Code
769-2393
Country
Japan
Facility Name
Tachikawa Hospital
City
Tachikawa-shi
ZIP/Postal Code
190-8531
Country
Japan
Facility Name
Mishuku Hospital
City
Tokyo
ZIP/Postal Code
153-0051
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
TOYOTA Memorial Hospital
City
Toyota-shi
ZIP/Postal Code
471-8513
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Auckland City Hospital (Auckland District Health Board)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Middlemore Clinical Trials Trust trading as Middlemore Clinical Trials
City
Auckland
Country
New Zealand
Facility Name
Lipid and Diabetes Research Group
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waitemata District Health Board- North Shore Hospital
City
North Shore
ZIP/Postal Code
622
Country
New Zealand
Facility Name
Endocrine, Diabetes & Research Centre (Capital and Coast District Health Board)
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-223-1017
Description
Gilead Clinical Trials Website

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease

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