Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
NCT ID: NCT04026165
Last Updated: 2022-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
384 participants
INTERVENTIONAL
2019-07-24
2021-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Selonsertib
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.
SEL
Tablet administered orally once daily
Placebo
Tablet administered orally once daily
Placebo
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.
SEL
Tablet administered orally once daily
Placebo
Tablet administered orally once daily
Interventions
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SEL
Tablet administered orally once daily
Placebo
Tablet administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Arizona Kidney Disease and Hypertension Centers
Glendale, Arizona, United States
AKDHC Medical Research Services, LLC
Tucson, Arizona, United States
Clearview Medical Research, LLC
Canyon Country, California, United States
Kidney Disease Medical Group, Inc.
Glendale, California, United States
Renal Consultants Medical Group
Granada Hills, California, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
California Institute of Renal Research
La Mesa, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
Rose Salter Medical Research Foundation
Newport Beach, California, United States
Valley Renal Medical Group Research
Northridge, California, United States
California Institute of Renal Research
San Diego, California, United States
California Kidney Specialist
San Dimas, California, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
New West Physicians, Inc
Golden, Colorado, United States
Western Nephrology and Metabolic Bone Disease, PC
Westminster, Colorado, United States
Omega Research Maitland, LLC
DeBary, Florida, United States
South Florida Research Institute
Lauderdale Lakes, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Discovery Medical Research Group, Inc
Ocala, Florida, United States
Coastal Nephrology Associates Research Center, LLC. D/B/A Volunteer Medical Research
Port Charlotte, Florida, United States
Atlanta Center for Clinical Research
Atlanta, Georgia, United States
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Boise Kidney & Hypertension, PLLC
Meridian, Idaho, United States
Research By Design, LLC
Chicago, Illinois, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States
Four Rivers Clinical Research
Paducah, Kentucky, United States
Internal Medicine Specialists, Inc
New Orleans, Louisiana, United States
Northwest Louisiana Nephrology L.L.C
Shreveport, Louisiana, United States
Aa Mrc, Llc
Flint, Michigan, United States
Elite Research Center
Flint, Michigan, United States
Arcturus Healthcare, PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
Pelican Point Dialysis - DaVita Clinical Research
Las Vegas, Nevada, United States
Albany Medical College
Albany, New York, United States
North Shore University Hospital: Division of Nephrology
Great Neck, New York, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, United States
CHEAR Center LLC
The Bronx, New York, United States
Mountain Kidney and Hypertension Associates
Asheville, North Carolina, United States
Mountain Diabetes & Endocrine Center
Asheville, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Diabetes And Endocrinology Consultants, P.C.
Morehead City, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
PMG Research Inc., d/b/a PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
SV Research LLC
Marion, Ohio, United States
Midwest Nephrology Group, PLLC
Midwest City, Oklahoma, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States
Lifespan Clinical Research Center
East Providence, Rhode Island, United States
PMG Research Of Charleston, LLC
Mt. Pleasant, South Carolina, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States
PMG Research, Inc d/b/a/ PMG Research of Knoxville
Knoxville, Tennessee, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
PMG Research, Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, United States
Memphis Veteran Affairs Medical Center
Memphis, Tennessee, United States
Arlington Nephrology
Arlington, Texas, United States
Corsicana Medical Research, LLC
Corsicana, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
The Medical Group of Texas
Fort Worth, Texas, United States
Primecare Medical Group
Houston, Texas, United States
DaVita Clinical Research
Houston, Texas, United States
Mercury Clinical Research
Houston, Texas, United States
DaVita Clinical Research
Lewisville, Texas, United States
Houston Methodist Research Institute - CCAT Pearland
Pearland, Texas, United States
Northeast Clinical Research of San Antonio
San Antonio, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Austin Health and University of Melbourne
Heidelberg, Victoria, Australia
St. Vincent Hospital, Melbourne
Fitzroy, , Australia
Royal Melbourne Hospital
Parkville, , Australia
LMC Clinical Research Inc. (Barrie)
Barrie, , Canada
LMC Clinical Research Inc. (Brampton)
Brampton, , Canada
LMC Clinical research Inc. (Thornhill)
Concord, , Canada
LMC Clinical Research Inc. (Etobicoke)
Etobicoke, , Canada
Clinical Research Solution Inc.
Kitchener, , Canada
Centre de Recherche Clinique de Lava
Laval, , Canada
Dr TGElliott Inc dba BC Diabetes
Vancouver, , Canada
Winnipeg Clinic
Winnipeg, , Canada
Asahikawa Medical University Hospital
Asahikawa, , Japan
National Hospital Organization Chiba-East-Hospital
Chiba, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Kokura Memorial Hospital
Kitakyushu-shi, , Japan
Yamanashi Prefectural Central Hospital
Kofu, , Japan
Kurobe City Hospital
Kurobe-shi, , Japan
Kurume University Hospital
Kurume-shi, , Japan
Nakamoto Medical Clinic
Mito, , Japan
Kozawa Eye Hospital and Diabetes Center
Mito, , Japan
Japanese Red Cross Musashino Hospital
Musashino, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
Nagoya, , Japan
Daido Clinic
Nagoya, , Japan
Nakakinen Clinic
Naka, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka General Medical Center
Osaka, , Japan
Hoshina Clinic
Saitama-shi, , Japan
Sanuki Municipal Hospital
Sanuki-shi, , Japan
Tachikawa Hospital
Tachikawa-shi, , Japan
Mishuku Hospital
Tokyo, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
TOYOTA Memorial Hospital
Toyota-shi, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Auckland City Hospital (Auckland District Health Board)
Auckland, , New Zealand
Middlemore Clinical Trials Trust trading as Middlemore Clinical Trials
Auckland, , New Zealand
Lipid and Diabetes Research Group
Christchurch, , New Zealand
Waitemata District Health Board- North Shore Hospital
North Shore, , New Zealand
Endocrine, Diabetes & Research Centre (Capital and Coast District Health Board)
Wellington, , New Zealand
Countries
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References
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Heerspink HJL, Perkovic V, Tuttle KR, Pergola PE, Mahaffey KW, Patel UD, Ishida JH, Kuo A, Chen F, Kustra R, Petrovic V, Rossing P, Kashihara N, Chertow GM. Selonsertib in Patients with Diabetic Kidney Disease: A Phase 2b Randomized Active Run-In Clinical Trial. J Am Soc Nephrol. 2024 Dec 1;35(12):1726-1736. doi: 10.1681/ASN.0000000000000444. Epub 2024 Jul 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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JapicCTI-194911
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-003951-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-223-1017
Identifier Type: -
Identifier Source: org_study_id