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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04026165




Registration number
NCT04026165
Ethics application status
Date submitted
17/07/2019
Date registered
19/07/2019

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
Scientific 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
Secondary ID [1] 0 0
JapicCTI-194911
Secondary ID [2] 0 0
GS-US-223-1017
Universal Trial Number (UTN)
Trial acronym
MOSAIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SEL
Treatment: Drugs - Placebo

Experimental: 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.

Placebo comparator: 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.


Treatment: Drugs: SEL
Tablet administered orally once daily

Treatment: Drugs: Placebo
Tablet administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr)
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
eGFRcr Slope
Timepoint [2] 0 0
Treatment-specific Baselines through Week 84
Secondary outcome [1] 0 0
Percentage of Participants With Kidney Clinical Events at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Time From Randomization to First Occurrence of a Kidney Clinical Event: Event Rate Per 100 Participant-years for First Occurrence of Kidney Clinical Event
Timepoint [2] 0 0
From randomization up to Week 101
Secondary outcome [3] 0 0
Pre-run-in Baseline Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys)
Timepoint [3] 0 0
Pre-run-in Baseline (Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values)
Secondary outcome [4] 0 0
eGFRcys Slope
Timepoint [4] 0 0
Pre-run-in Baseline through Week 84

Eligibility
Key inclusion criteria
Key

* 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

Key
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/09/2021
Sample size
Target
Accrual to date
Final
384
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health and University of Melbourne - Heidelberg
Recruitment hospital [2] 0 0
St. Vincent Hospital, Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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Florida
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Georgia
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Hawaii
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Idaho
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United States of America
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Michigan
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Missouri
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Nevada
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Canada
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Barrie
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Canada
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Brampton
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Canada
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Concord
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Canada
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Etobicoke
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Canada
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Kitchener
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Canada
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Laval
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Canada
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Vancouver
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Canada
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Winnipeg
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Japan
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Asahikawa
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Japan
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Chiba
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Japan
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Kagoshima
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Japan
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Kitakyushu-shi
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Japan
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Kofu
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Japan
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Kurobe-shi
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Japan
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Kurume-shi
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Japan
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Mito-shi
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Japan
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Musashino
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Nagasaki
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Nagoya-shi
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Japan
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Naka-shi
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama-shi
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Japan
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Sanuki-shi
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Japan
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Tachikawa-shi
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Tokyo
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Toyota-shi
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Japan
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Yokohama-shi
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New Zealand
State/province [55] 0 0
Auckland
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New Zealand
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Christchurch
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New Zealand
State/province [57] 0 0
North Shore
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New Zealand
State/province [58] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04026165