Study Evaluating the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease (MOSAIC)
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ClinicalTrials.gov Identifier: NCT04026165 |
Recruitment Status :
Active, not recruiting
First Posted : July 19, 2019
Last Update Posted : January 26, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Kidney Disease | Drug: SEL Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | July 24, 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |

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 |
- Estimated Glomerular Filtration Rate Based on Creatinine (eGFRcr) Slope [ Time Frame: Up to 100 weeks ]
- Proportion of Kidney Clinical Events at Week 48 [ Time Frame: 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 [ Time Frame: Up to 100 weeks ]
- Estimated Glomerular Filtration Rate Based on Cystatin C (eGFRcys) Slope [ Time Frame: Up to 100 weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines.
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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
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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
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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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026165

Study Director: | Gilead Study Director | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT04026165 |
Other Study ID Numbers: |
GS-US-223-1017 JapicCTI-194911 ( Registry Identifier: Japan Pharmaceutical Information Center ) |
First Posted: | July 19, 2019 Key Record Dates |
Last Update Posted: | January 26, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Diseases Diabetic Nephropathies Urologic Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |