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Trial record 5 of 30 for:    Gilead | Asheville, North Carolina, U.S.

Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease (MOSAIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026165
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE July 24, 2019
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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) ]
  • 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.
  • Time From Randomization to Adjudicated CV Death [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
  • Time from Randomization to Adjudicated Atrial Fibrillation [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
  • Time From Randomization to Adjudicated CV Death or Adjudicated Kidney Failure [ Time Frame: Randomization up to end of study (median treatment duration: 20 months) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Kidney Disease
Intervention  ICMJE
  • Drug: SEL
    Tablet administered orally once daily
  • Drug: Placebo
    Tablet administered orally once daily
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: SEL
    • Drug: Placebo
  • 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.

    Interventions:
    • Drug: SEL
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
3300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE United States,   Australia,   Canada,   Japan,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026165
Other Study ID Numbers  ICMJE GS-US-223-1017
2018-003951-39 ( EudraCT Number )
JapicCTI-194911 ( Registry Identifier: Japan Pharmaceutical Information Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP