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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT04026165

Collaborator

(none)

310

Enrollment

111

Locations

Arms

25.4

Actual Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Kidney Disease	Drug: SEL Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

310 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 24, 2019

Actual Primary Completion Date :

Sep 3, 2021

Actual Study Completion Date :

Sep 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Selonsertib Run-in Period (5 Weeks): Participants will receive placebo for at least one week and then SEL 18 mg for at least 4 weeks. Double-Blind Treatment: Participants will be randomized to receive SEL 18 mg until death, study drug discontinuation, kidney failure, or the global study end date.	Drug: SEL Tablet administered orally once daily Drug: Placebo Tablet administered orally once daily
Placebo Comparator: Placebo Run-in Period (5 Weeks): Participants will receive placebo for at least one week and then SEL 18 mg for at least 4 weeks. Double-Blind Treatment: Participants will be randomized to receive placebo until death, study drug discontinuation, kidney failure, or the global study end date.	Drug: SEL Tablet administered orally once daily Drug: Placebo Tablet administered orally once daily

Arm

Intervention/Treatment

Experimental: Selonsertib

Run-in Period (5 Weeks): Participants will receive placebo for at least one week and then SEL 18 mg for at least 4 weeks. Double-Blind Treatment: Participants will be randomized to receive SEL 18 mg until death, study drug discontinuation, kidney failure, or the global study end date.

Drug: SEL

Tablet administered orally once daily

Drug: Placebo

Tablet administered orally once daily

Placebo Comparator: Placebo

Run-in Period (5 Weeks): Participants will receive placebo for at least one week and then SEL 18 mg for at least 4 weeks. Double-Blind Treatment: Participants will be randomized to receive placebo until death, study drug discontinuation, kidney failure, or the global study end date.

Drug: SEL

Tablet administered orally once daily

Drug: Placebo

Tablet administered orally once daily

Outcome Measures

Primary Outcome Measures

Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr) Slope [Up to 100 weeks]

Secondary Outcome Measures

Proportion of Kidney Clinical Events at Week 48 [Week 48]
Kidney clinical event is 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 [Up to 100 weeks]
Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys) Slope [Up to 100 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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

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 CV 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Kidney Disease and Hypertension Centers	Glendale	Arizona	United States	85306
2	AKDHC Medical Research Services, LLC	Tucson	Arizona	United States	85712
3	Clearview Medical Research, LLC	Canyon Country	California	United States	91350
4	Kidney Disease Medical Group, Inc.	Glendale	California	United States	91206
5	Renal Consultants Medical Group	Granada Hills	California	United States	91344
6	Marin Endocrine Care & Research, Inc.	Greenbrae	California	United States	94904
7	California Institute of Renal Research	La Mesa	California	United States	91942-3059
8	Academic Medical Research Institute	Los Angeles	California	United States	90022
9	Rose Salter Medical Research Foundation	Newport Beach	California	United States	92663
10	Valley Renal Medical Group Research	Northridge	California	United States	91324
11	California Institute of Renal Research	San Diego	California	United States	92123
12	California Kidney Specialist	San Dimas	California	United States	91773
13	Creekside Endocrine Associates, PC	Denver	Colorado	United States	80246
14	New West Physicians, Inc	Golden	Colorado	United States	80401
15	Western Nephrology and Metabolic Bone Disease, PC	Westminster	Colorado	United States	80031
16	Omega Research Maitland, LLC	DeBary	Florida	United States	32713
17	South Florida Research Institute	Lauderdale Lakes	Florida	United States	33313
18	Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
19	Discovery Medical Research Group, Inc	Ocala	Florida	United States	34471
20	Coastal Nephrology Associates Research Center, LLC. D/B/A Volunteer Medical Research	Port Charlotte	Florida	United States	33952
21	Atlanta Center for Clinical Research	Atlanta	Georgia	United States	30342
22	Georgia Nephrology Research Institute	Lawrenceville	Georgia	United States	30046
23	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
24	Boise Kidney & Hypertension, PLLC	Meridian	Idaho	United States	83642
25	Research By Design, LLC	Chicago	Illinois	United States	60643
26	Buynak Clinical Research, P.C.	Valparaiso	Indiana	United States	46383
27	West Broadway Clinic	Council Bluffs	Iowa	United States	51501
28	Kansas Nephrology Research Institute, LLC	Wichita	Kansas	United States	67214
29	Four Rivers Clinical Research	Paducah	Kentucky	United States	42003
30	Internal Medicine Specialists, Inc	New Orleans	Louisiana	United States	70115
31	Northwest Louisiana Nephrology L.L.C	Shreveport	Louisiana	United States	71101
32	Aa Mrc, Llc	Flint	Michigan	United States	48504
33	Elite Research Center	Flint	Michigan	United States	48532
34	Arcturus Healthcare, PLC, Troy Internal Medicine Research Division	Troy	Michigan	United States	48098
35	Clinical Research Consultants, LLC	Kansas City	Missouri	United States	64111
36	Pelican Point Dialysis - DaVita Clinical Research	Las Vegas	Nevada	United States	89129
37	Albany Medical College	Albany	New York	United States	12206
38	CHEAR Center LLC	Bronx	New York	United States	10455
39	North Shore University Hospital: Division of Nephrology	Great Neck	New York	United States	11021
40	Endocrine Associates of Long Island, PC	Smithtown	New York	United States	11787
41	Mountain Kidney and Hypertension Associates	Asheville	North Carolina	United States	28801
42	Mountain Diabetes & Endocrine Center	Asheville	North Carolina	United States	28803
43	Carteret Medical Group	Morehead City	North Carolina	United States	28557
44	Diabetes And Endocrinology Consultants, P.C.	Morehead City	North Carolina	United States	28557
45	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina	United States	27804
46	PMG Research Inc., d/b/a PMG Research of Piedmont Healthcare	Statesville	North Carolina	United States	28625
47	Wilmington Health, PLLC	Wilmington	North Carolina	United States	28401
48	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
49	SV Research LLC	Marion	Ohio	United States	43302
50	Midwest Nephrology Group, PLLC	Midwest City	Oklahoma	United States	73130
51	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania	United States	15009
52	Northeast Clinical Research Center, LLC	Bethlehem	Pennsylvania	United States	18017
53	Lifespan Clinical Research Center	East Providence	Rhode Island	United States	02915
54	PMG Research Of Charleston, LLC	Mount Pleasant	South Carolina	United States	29464
55	Southeast Renal Research Institute	Chattanooga	Tennessee	United States	37408
56	University Diabetes and Endocrine Consultants	Chattanooga	Tennessee	United States	37411
57	PMG Research, Inc d/b/a/ PMG Research of Knoxville	Knoxville	Tennessee	United States	37912
58	Knoxville Kidney Center, PLLC	Knoxville	Tennessee	United States	37923
59	PMG Research, Inc. d/b/a PMG Research of Knoxville	Knoxville	Tennessee	United States	37938
60	Memphis Veteran Affairs Medical Center	Memphis	Tennessee	United States	38104
61	Arlington Nephrology	Arlington	Texas	United States	76015
62	Corsicana Medical Research, LLC	Corsicana	Texas	United States	75110
63	North Texas Endocrine Center	Dallas	Texas	United States	75231
64	The Medical Group of Texas	Fort Worth	Texas	United States	76116
65	Primecare Medical Group	Houston	Texas	United States	77024
66	DaVita Clinical Research	Houston	Texas	United States	77030
67	Mercury Clinical Research	Houston	Texas	United States	77036
68	DaVita Clinical Research	Lewisville	Texas	United States	75057
69	Houston Methodist Research Institute - CCAT Pearland	Pearland	Texas	United States	77584
70	Northeast Clinical Research of San Antonio	San Antonio	Texas	United States	78154
71	Clinical Advancement Center, PLLC	San Antonio	Texas	United States	78215
72	Austin Health and University of Melbourne	Heidelberg	Victoria	Australia	3081
73	St. Vincent Hospital, Melbourne	Fitzroy		Australia	3065
74	Royal Melbourne Hospital	Parkville		Australia	3052
75	LMC Clinical Research Inc. (Barrie)	Barrie		Canada	L4M 7G1
76	LMC Clinical Research Inc. (Brampton)	Brampton		Canada	L6S 0C6
77	LMC Clinical research Inc. (Thornhill)	Concord		Canada	L4K 4M2
78	LMC Clinical Research Inc. (Etobicoke)	Etobicoke		Canada	M9R 4E1
79	Clinical Research Solution Inc.	Kitchener		Canada	N2H 5Z8
80	Centre de Recherche Clinique de Lava	Laval		Canada	H7T 2P5
81	Dr TGElliott Inc dba BC Diabetes	Vancouver		Canada	V5Y 3W2
82	Winnipeg Clinic	Winnipeg		Canada	R3C 0N2
83	Asahikawa Medical University Hospital	Asahikawa		Japan	078-8510
84	National Hospital Organization Chiba-East-Hospital	Chiba		Japan	260-0801
85	Kagoshima University Hospital	Kagoshima		Japan	890-8520
86	Kokura Memorial Hospital	Kitakyushu-shi		Japan	802-8555
87	Yamanashi Prefectural Central Hospital	Kofu		Japan	400-0027
88	Kurobe City Hospital	Kurobe-shi		Japan	938-8502
89	Kurume University Hospital	Kurume-shi		Japan	830-0011
90	Nakamoto Medical Clinic	Mito-shi		Japan	310-0826
91	Kozawa Eye Hospital and Diabetes Center	Mito-shi		Japan	310-0845
92	Japanese Red Cross Musashino Hospital	Musashino		Japan	180-8610
93	Nagasaki University Hospital	Nagasaki		Japan	852-8501
94	Japan Organization of Occupational Health and Safety Chubu Rosai Hospital	Nagoya-shi		Japan	455-8530
95	Daido Clinic	Nagoya-shi		Japan	457-8511
96	Nakakinen Clinic	Naka-shi		Japan	311-0113
97	Niigata University Medical & Dental Hospital	Niigata		Japan	9518520
98	Okayama University Hospital	Okayama		Japan	700-8558
99	Osaka General Medical Center	Osaka		Japan	558-8558
100	Hoshina Clinic	Saitama-shi		Japan	338-0837
101	Sanuki Municipal Hospital	Sanuki-shi		Japan	769-2393
102	Tachikawa Hospital	Tachikawa-shi		Japan	190-8531
103	Mishuku Hospital	Tokyo		Japan	153-0051
104	Nihon University Itabashi Hospital	Tokyo		Japan	173-8610
105	TOYOTA Memorial Hospital	Toyota-shi		Japan	471-8513
106	Yokohama City University Hospital	Yokohama-shi		Japan	236-0004
107	Auckland City Hospital (Auckland District Health Board)	Auckland		New Zealand	1023
108	Middlemore Clinical Trials Trust trading as Middlemore Clinical Trials	Auckland		New Zealand
109	Lipid and Diabetes Research Group	Christchurch		New Zealand	8011
110	Waitemata District Health Board- North Shore Hospital	North Shore		New Zealand	622
111	Endocrine, Diabetes & Research Centre (Capital and Coast District Health Board)	Wellington		New Zealand	6021

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT04026165

Other Study ID Numbers:

GS-US-223-1017
JapicCTI-194911

First Posted:

Jul 19, 2019

Last Update Posted:

Sep 24, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Diabetic Nephropathies

Study Results

No Results Posted as of Sep 24, 2021