AzTrials
AzTrials

Diabetic Kidney DiseasePhase 2MOSAICNCT04026165

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

A Phase 2 study testing SEL in people with Diabetic Kidney Disease, run by Gilead Sciences at 111 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
SEL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
384 participants
Where
111 sitesin 5 countries
Study dates
24 Jul 2019to 3 Sep 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

111 sites in 5 countries.

111 sites in 5 countries

United States71 sites

  • Albany Medical College

    Albany, New York, 12206

  • Arlington Nephrology

    Arlington, Texas, 76015

  • Mountain Kidney and Hypertension Associates

    Asheville, North Carolina, 28801

  • Mountain Diabetes & Endocrine Center

    Asheville, North Carolina, 28803

  • Atlanta Center for Clinical Research

    Atlanta, Georgia, 30342

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • Clearview Medical Research, LLC

    Canyon Country, California, 91350

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37408

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Research By Design, LLC

    Chicago, Illinois, 60643

  • Corsicana Medical Research, LLC

    Corsicana, Texas, 75110

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Omega Research Maitland, LLC

    DeBary, Florida, 32713

  • Creekside Endocrine Associates, PC

    Denver, Colorado, 80246

  • Lifespan Clinical Research Center

    East Providence, Rhode Island, 02915

  • Aa Mrc, Llc

    Flint, Michigan, 48504

  • Elite Research Center

    Flint, Michigan, 48532

  • The Medical Group of Texas

    Fort Worth, Texas, 76116

  • Arizona Kidney Disease and Hypertension Centers

    Glendale, Arizona, 85306

  • Kidney Disease Medical Group, Inc.

    Glendale, California, 91206

  • New West Physicians, Inc

    Golden, Colorado, 80401

  • Renal Consultants Medical Group

    Granada Hills, California, 91344

  • North Shore University Hospital: Division of Nephrology

    Great Neck, New York, 11021

  • Marin Endocrine Care & Research, Inc.

    Greenbrae, California, 94904

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Primecare Medical Group

    Houston, Texas, 77024

  • DaVita Clinical Research

    Houston, Texas, 77030

  • Mercury Clinical Research

    Houston, Texas, 77036

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

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

    Knoxville, Tennessee, 37912

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923

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

    Knoxville, Tennessee, 37938

  • California Institute of Renal Research

    La Mesa, California, 91942-3059

  • Pelican Point Dialysis - DaVita Clinical Research

    Las Vegas, Nevada, 89129

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313

  • Georgia Nephrology Research Institute

    Lawrenceville, Georgia, 30046

  • DaVita Clinical Research

    Lewisville, Texas, 75057

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • SV Research LLC

    Marion, Ohio, 43302

  • Memphis Veteran Affairs Medical Center

    Memphis, Tennessee, 38104

  • Boise Kidney & Hypertension, PLLC

    Meridian, Idaho, 83642

  • Midwest Nephrology Group, PLLC

    Midwest City, Oklahoma, 73130

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Diabetes And Endocrinology Consultants, P.C.

    Morehead City, North Carolina, 28557

  • PMG Research Of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Internal Medicine Specialists, Inc

    New Orleans, Louisiana, 70115

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Rose Salter Medical Research Foundation

    Newport Beach, California, 92663

  • Valley Renal Medical Group Research

    Northridge, California, 91324

  • Discovery Medical Research Group, Inc

    Ocala, Florida, 34471

  • Four Rivers Clinical Research

    Paducah, Kentucky, 42003

  • Houston Methodist Research Institute - CCAT Pearland

    Pearland, Texas, 77584

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

    Port Charlotte, Florida, 33952

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas, 78154

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78215

  • California Institute of Renal Research

    San Diego, California, 92123

  • California Kidney Specialist

    San Dimas, California, 91773

  • Northwest Louisiana Nephrology L.L.C

    Shreveport, Louisiana, 71101

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

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

    Statesville, North Carolina, 28625

  • CHEAR Center LLC

    The Bronx, New York, 10455

  • Arcturus Healthcare, PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • AKDHC Medical Research Services, LLC

    Tucson, Arizona, 85712

  • Buynak Clinical Research, P.C.

    Valparaiso, Indiana, 46383

  • Western Nephrology and Metabolic Bone Disease, PC

    Westminster, Colorado, 80031

  • Kansas Nephrology Research Institute, LLC

    Wichita, Kansas, 67214

  • Wilmington Health, PLLC

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan24 sites

  • Asahikawa Medical University Hospital

    Asahikawa, 078-8510

  • National Hospital Organization Chiba-East-Hospital

    Chiba, 260-0801

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kokura Memorial Hospital

    Kitakyushu-shi, 802-8555

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-0027

  • Kurobe City Hospital

    Kurobe-shi, 938-8502

  • Kurume University Hospital

    Kurume-shi, 830-0011

  • Nakamoto Medical Clinic

    Mito, 310-0826

  • Kozawa Eye Hospital and Diabetes Center

    Mito, 310-0845

  • Japanese Red Cross Musashino Hospital

    Musashino, 180-8610

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital

    Nagoya, 455-8530

  • Daido Clinic

    Nagoya, 457-8511

  • Nakakinen Clinic

    Naka, 311-0113

  • Niigata University Medical & Dental Hospital

    Niigata, 9518520

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka General Medical Center

    Osaka, 558-8558

  • Hoshina Clinic

    Saitama-shi, 338-0837

  • Sanuki Municipal Hospital

    Sanuki-shi, 769-2393

  • Tachikawa Hospital

    Tachikawa-shi, 190-8531

  • Mishuku Hospital

    Tokyo, 153-0051

  • Nihon University Itabashi Hospital

    Tokyo, 173-8610

  • TOYOTA Memorial Hospital

    Toyota-shi, 471-8513

  • Yokohama City University Hospital

    Yokohama, 236-0004

Other trials in Japan

Canada8 sites

  • LMC Clinical Research Inc. (Barrie)

    Barrie, L4M 7G1

  • LMC Clinical Research Inc. (Brampton)

    Brampton, L6S 0C6

  • LMC Clinical research Inc. (Thornhill)

    Concord, L4K 4M2

  • LMC Clinical Research Inc. (Etobicoke)

    Etobicoke, M9R 4E1

  • Clinical Research Solution Inc.

    Kitchener, N2H 5Z8

  • Centre de Recherche Clinique de Lava

    Laval, H7T 2P5

  • Dr TGElliott Inc dba BC Diabetes

    Vancouver, V5Y 3W2

  • Winnipeg Clinic

    Winnipeg, R3C 0N2

Other trials in Canada

New Zealand5 sites

  • Auckland City Hospital (Auckland District Health Board)

    Auckland, 1023

  • Middlemore Clinical Trials Trust trading as Middlemore Clinical Trials

    Auckland

  • Lipid and Diabetes Research Group

    Christchurch, 8011

  • Waitemata District Health Board- North Shore Hospital

    North Shore, 622

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

    Wellington, 6021

Other trials in New Zealand

Australia3 sites

  • St. Vincent Hospital, Melbourne

    Fitzroy, 3065

  • Austin Health and University of Melbourne

    Heidelberg, Victoria, 3081

  • Royal Melbourne Hospital

    Parkville, 3052

Other trials in Australia

About this study

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

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).

Read the 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.

Being tested
SEL, Placebo
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SELDrug

    Tablet administered orally once daily

  • PlaceboDrug

    Tablet administered orally once daily

Study groups in NCT04026165
Study groupRoleWhat they receive
SelonsertibExperimentalRun-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.
Receives: Drug: SEL; Drug: Placebo
PlaceboPlacebo comparatorRun-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.
Receives: Drug: SEL; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: Treatment-specific Baselines through Week 84

Secondary outcomes (4)

  1. 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.

    Measured: Week 48

  2. 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.

    Measured: From randomization up to Week 101

  3. 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.

    Measured: Pre-run-in Baseline (Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values)

  4. 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.

    Measured: Pre-run-in Baseline through Week 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start24 Jul 2019
  3. Primary completion3 Sep 2021
  4. Study completion3 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Participants received Run-in and Randomized treatments sequentially and in the Randomized Phase, the treatments were assigned in parallel.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04026165
Sponsor's protocol ID
GS-US-223-1017
Other IDs
JapicCTI-194911, 2018-003951-39, 2018
Acronym
MOSAIC
Status last verified
Nov 2022
First submitted
17 Jul 2019
Last updated
21 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39018154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SEL in people with Diabetic Kidney Disease, run by Gilead Sciences at 111 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, Japan, Canada, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr) (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04026165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in