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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04026165
Registration number
NCT04026165
Ethics application status
Date submitted
17/07/2019
Date registered
19/07/2019
Date last updated
21/12/2022
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
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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
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Secondary ID [1]
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JapicCTI-194911
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Secondary ID [2]
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GS-US-223-1017
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Universal Trial Number (UTN)
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Trial acronym
MOSAIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment-specific Baseline Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr)
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Assessment method [1]
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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.
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Timepoint [1]
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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)
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Primary outcome [2]
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eGFRcr Slope
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Assessment method [2]
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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.
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Timepoint [2]
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Treatment-specific Baselines through Week 84
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Secondary outcome [1]
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Percentage of Participants With Kidney Clinical Events at Week 48
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Assessment method [1]
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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.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Time From Randomization to First Occurrence of a Kidney Clinical Event: Event Rate Per 100 Participant-years for First Occurrence of Kidney Clinical Event
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization up to Week 101
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Secondary outcome [3]
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Pre-run-in Baseline Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys)
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Assessment method [3]
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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.
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Timepoint [3]
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Pre-run-in Baseline (Pre-run in Baseline = Average of visit A (Enrollment) and Visit B (7-14 days after Visit A) eGFRcys values)
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Secondary outcome [4]
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eGFRcys Slope
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Assessment method [4]
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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.
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Timepoint [4]
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Pre-run-in Baseline through Week 84
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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
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Minimum age
18
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/09/2021
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Sample size
Target
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Accrual to date
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Final
384
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health and University of Melbourne - Heidelberg
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Recruitment hospital [2]
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St. Vincent Hospital, Melbourne - Fitzroy
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Recruitment hospital [3]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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3081 - Heidelberg
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
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Arizona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04026165
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04026165
Download to PDF