STATUS Study Complete

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Study Complete

GILEAD STUDY ID

GS-US-223-1017

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

December 21, 2022

Clinicaltrials.gov ID

NCT04026165

EudraCT ID

2018-003951-39

STUDY DOCUMENTS

View study documents

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)

PROTOCOL 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).

Participation requirements

Age

18 years - 80 years

Sex

All

Healthy Volunteers

Study details

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
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.

Locations

Locations (111)

Arizona Kidney Disease and Hypertension Centers

Glendale, Arizona, United States, 85306

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

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

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

North Shore University Hospital: Division of Nephrology

Endocrine Associates of Long Island, PC

CHEAR Center LLC

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