Study Details

OVERVIEW

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 (MOSAIC)

Participation Requirements

Age

18 Years - 80 Years

Sex

All

Healthy Volunteers

Medical Condition

Diabetic Kidney Disease

Gender

N/A

Date

July 2019 - September 2021

Study Type

Interventional

Study Phase

Phase 2

Product

SEL, Placebo

Eligibility Information

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

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.

Locations

Locations (111)

Arizona Kidney Disease and Hypertension Centers

Glendale, Arizona, United States, 85306

AKDHC Medical Research Services, LLC

Tucson, Arizona, United States, 85712

Clearview Medical Research, LLC

Canyon Country, California, United States, 91350

Kidney Disease Medical Group, Inc.

Glendale, California, United States, 91206

Renal Consultants Medical Group

Granada Hills, California, United States, 91344

Marin Endocrine Care & Research, Inc.

Greenbrae, California, United States, 94904

California Institute of Renal Research

La Mesa, California, United States, 91942-3059

Academic Medical Research Institute

Los Angeles, California, United States, 90022

Rose Salter Medical Research Foundation

Newport Beach, California, United States, 92663

Valley Renal Medical Group Research

Northridge, California, United States, 91324

California Institute of Renal Research

San Diego, California, United States, 92123

California Kidney Specialist

San Dimas, California, United States, 91773

Creekside Endocrine Associates, PC

Denver, Colorado, United States, 80246

New West Physicians, Inc

Golden, Colorado, United States, 80401

Western Nephrology and Metabolic Bone Disease, PC

Westminster, Colorado, United States, 80031

Omega Research Maitland, LLC

DeBary, Florida, United States, 32713

South Florida Research Institute

Lauderdale Lakes, Florida, United States, 33313

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States, 34652

Discovery Medical Research Group, Inc

Ocala, Florida, United States, 34471

Coastal Nephrology Associates Research Center, LLC. D/B/A Volunteer Medical Research

Port Charlotte, Florida, United States, 33952

Atlanta Center for Clinical Research

Atlanta, Georgia, United States, 30342

Georgia Nephrology Research Institute

Lawrenceville, Georgia, United States, 30046

East-West Medical Research Institute

Honolulu, Hawaii, United States, 96814

Boise Kidney & Hypertension, PLLC

Meridian, Idaho, United States, 83642

Research By Design, LLC

Chicago, Illinois, United States, 60643

Buynak Clinical Research, P.C.

Valparaiso, Indiana, United States, 46383

West Broadway Clinic

Council Bluffs, Iowa, United States, 51501

Kansas Nephrology Research Institute, LLC

Wichita, Kansas, United States, 67214

Four Rivers Clinical Research

Paducah, Kentucky, United States, 42003

Internal Medicine Specialists, Inc

New Orleans, Louisiana, United States, 70115

Northwest Louisiana Nephrology L.L.C

Shreveport, Louisiana, United States, 71101

Aa Mrc, Llc

Flint, Michigan, United States, 48504

Elite Research Center

Flint, Michigan, United States, 48532

Arcturus Healthcare, PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States, 48098

Clinical Research Consultants, LLC

Kansas City, Missouri, United States, 64111

Pelican Point Dialysis - DaVita Clinical Research

Las Vegas, Nevada, United States, 89129

Albany Medical College

Albany, New York, United States, 12206

CHEAR Center LLC

Bronx, New York, United States, 10455

North Shore University Hospital: Division of Nephrology

Great Neck, New York, United States, 11021

Endocrine Associates of Long Island, PC

Smithtown, New York, United States, 11787

Mountain Kidney and Hypertension Associates

Asheville, North Carolina, United States, 28801

Mountain Diabetes & Endocrine Center

Asheville, North Carolina, United States, 28803

Carteret Medical Group

Morehead City, North Carolina, United States, 28557

Diabetes And Endocrinology Consultants, P.C.

Morehead City, North Carolina, United States, 28557

PMG Research of Rocky Mount, LLC

Rocky Mount, North Carolina, United States, 27804

PMG Research Inc., d/b/a PMG Research of Piedmont Healthcare

Statesville, North Carolina, United States, 28625

Wilmington Health, PLLC

Wilmington, North Carolina, United States, 28401

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States, 27103

SV Research LLC

Marion, Ohio, United States, 43302

Midwest Nephrology Group, PLLC

Midwest City, Oklahoma, United States, 73130

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, United States, 15009

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania, United States, 18017

Lifespan Clinical Research Center

East Providence, Rhode Island, United States, 02915

PMG Research Of Charleston, LLC

Mount Pleasant, South Carolina, United States, 29464

Southeast Renal Research Institute

Chattanooga, Tennessee, United States, 37408

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, United States, 37411

PMG Research, Inc d/b/a/ PMG Research of Knoxville

Knoxville, Tennessee, United States, 37912

Knoxville Kidney Center, PLLC

Knoxville, Tennessee, United States, 37923

PMG Research, Inc. d/b/a PMG Research of Knoxville

Knoxville, Tennessee, United States, 37938

Memphis Veteran Affairs Medical Center

Memphis, Tennessee, United States, 38104

Arlington Nephrology

Arlington, Texas, United States, 76015

Corsicana Medical Research, LLC

Corsicana, Texas, United States, 75110

North Texas Endocrine Center

Dallas, Texas, United States, 75231

The Medical Group of Texas

Fort Worth, Texas, United States, 76116

Primecare Medical Group

Houston, Texas, United States, 77024

DaVita Clinical Research

Houston, Texas, United States, 77030

Mercury Clinical Research

Houston, Texas, United States, 77036

DaVita Clinical Research

Lewisville, Texas, United States, 75057

Houston Methodist Research Institute - CCAT Pearland

Pearland, Texas, United States, 77584

Northeast Clinical Research of San Antonio

San Antonio, Texas, United States, 78154

Clinical Advancement Center, PLLC

San Antonio, Texas, United States, 78215

Austin Health and University of Melbourne

Heidelberg, Victoria, Australia, 3081

St. Vincent Hospital, Melbourne

Fitzroy, Australia, 3065

Royal Melbourne Hospital

Parkville, Australia, 3052

LMC Clinical Research Inc. (Barrie)

Barrie, Canada, L4M 7G1

LMC Clinical Research Inc. (Brampton)

Brampton, Canada, L6S 0C6

LMC Clinical research Inc. (Thornhill)

Concord, Canada, L4K 4M2

LMC Clinical Research Inc. (Etobicoke)

Etobicoke, Canada, M9R 4E1

Clinical Research Solution Inc.

Kitchener, Canada, N2H 5Z8

Centre de Recherche Clinique de Lava

Laval, Canada, H7T 2P5

Dr TGElliott Inc dba BC Diabetes

Vancouver, Canada, V5Y 3W2

Winnipeg Clinic

Winnipeg, Canada, R3C 0N2

Asahikawa Medical University Hospital

Asahikawa, Japan, 078-8510

National Hospital Organization Chiba-East-Hospital

Chiba, Japan, 260-0801

Kagoshima University Hospital

Kagoshima, Japan, 890-8520

Kokura Memorial Hospital

Kitakyushu-shi, Japan, 802-8555

Yamanashi Prefectural Central Hospital

Kofu, Japan, 400-0027

Kurobe City Hospital

Kurobe-shi, Japan, 938-8502

Kurume University Hospital

Kurume-shi, Japan, 830-0011

Nakamoto Medical Clinic

Mito-shi, Japan, 310-0826

Kozawa Eye Hospital and Diabetes Center

Mito-shi, Japan, 310-0845

Japanese Red Cross Musashino Hospital

Musashino, Japan, 180-8610

Nagasaki University Hospital

Nagasaki, Japan, 852-8501

Japan Organization of Occupational Health and Safety Chubu Rosai Hospital

Nagoya-shi, Japan, 455-8530

Daido Clinic

Nagoya-shi, Japan, 457-8511

Nakakinen Clinic

Naka-shi, Japan, 311-0113

Niigata University Medical & Dental Hospital

Niigata, Japan, 9518520

Okayama University Hospital

Okayama, Japan, 700-8558

Osaka General Medical Center

Osaka, Japan, 558-8558

Hoshina Clinic

Saitama-shi, Japan, 338-0837

Sanuki Municipal Hospital

Sanuki-shi, Japan, 769-2393

Tachikawa Hospital

Tachikawa-shi, Japan, 190-8531

Mishuku Hospital

Tokyo, Japan, 153-0051

Nihon University Itabashi Hospital

Tokyo, Japan, 173-8610

TOYOTA Memorial Hospital

Toyota-shi, Japan, 471-8513

Yokohama City University Hospital

Yokohama-shi, Japan, 236-0004

Auckland City Hospital (Auckland District Health Board)

Auckland, New Zealand, 1023

Middlemore Clinical Trials Trust trading as Middlemore Clinical Trials

Auckland, New Zealand

Lipid and Diabetes Research Group

Christchurch, New Zealand, 8011

Waitemata District Health Board- North Shore Hospital

North Shore, New Zealand, 622

Endocrine, Diabetes & Research Centre (Capital and Coast District Health Board)

Wellington, New Zealand, 6021

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (111)

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