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Trial record 1 of 1 for:    GS-US-223-1017
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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 : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function, reduce the risk of kidney failure, or reduce the risk of death due to kidney disease in participants with diabetic kidney disease (DKD).

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: SEL Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, 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 : December 2024
Estimated Study Completion Date : December 2024

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Arms and Interventions
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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 transplantation, or the global study end date. Participants will remain on study drug even after a primary clinical endpoint is reached.

 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 transplantation, or the global study end date. Participants will remain on study drug even after a primary clinical endpoint is reached.

 Drug: SEL
Tablet administered orally once daily

Drug: Placebo
Tablet administered orally once daily


Outcome Measures
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Primary Outcome Measures :
  1. Time From Randomization to Clinical Endpoint [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]

    Clinical endpoint is defined as time from randomization to the first occurrence of any of the following adjudicated events:

    1. Confirmed ≥ 40% decline in estimated glomerular filtration rate (eGFR) from baseline, or
    2. Kidney failure (dialysis for at least 90 days, kidney transplantation, or confirmed decrease in eGFR to < 15 mL/min/1.73 m^2 for participants without dialysis or kidney transplantation), or
    3. Death due to kidney disease

  2. eGFR Slope [ Time Frame: Randomization up to Week 108 ]
    The difference in eGFR slope between SEL and placebo groups will be estimated and tested when 700 randomized participants complete the Week 108 visit or discontinue from study.


Secondary Outcome Measures :
  1. Time From Randomization to Adjudicated Cardiovascular (CV) Death or Hospitalization for Heart Failure [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
  2. Time From Randomization to the First Occurrence of an Adjudicated Event in the CV Composite Endpoint [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
    The CV composite endpoint includes CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure.

  3. Time From Randomization to Adjudicated CV Death [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
  4. Time from Randomization to Adjudicated Atrial Fibrillation [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
  5. Time From Randomization to Adjudicated CV Death or Adjudicated Kidney Failure [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
  6. Time From Randomization to Adjudicated All-Cause Death or Adjudicated Kidney Failure [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]

Eligibility Criteria
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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
Criteria

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
      • b: eGFR (mL/min/1.73 m^2): ≥ 30 to < 45; UACR (mg/g): ≥ 300
      • c: eGFR (mL/min/1.73 m^2): ≥ 20 to < 30; UACR (mg/g): ≥ 150

  • 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 within 30 days prior to enrollment

Key Exclusion Criteria:

  • HbA1c > 12.0% within 30 days prior to enrollment
  • If < 30 years of age, any history of chronic insulin therapy or diabetic ketoacidosis
  • Body mass index (BMI) > 50 kg/m^2
  • UACR > 5000 mg/g on any measurement during screening
  • End stage renal disease (ESRD) (i.e., peritoneal dialysis, hemodialysis, or history of kidney transplantation)
  • Anticipated progression to ESRD (need for 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 a 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
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04026165    
Other Study ID Numbers: GS-US-223-1017
2018-003951-39 ( EudraCT Number )
JapicCTI-194911 ( Registry Identifier: Japan Pharmaceutical Information Center )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases