Dapagliflozin Effect on Cardiovascular Outcomes in Haemodialysis for End Stage Renal Disease

Sponsor
Tan Tock Seng Hospital
Study ID
NCT04764097
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

  • Cardiovascular Diseases
  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study aims to study SGLT2 inhibitors in patients who are undergoing haemodialysis for end stage renal disease and established ASCVD, to examine the safety and clinical outcomes, consisting of a composite of non-fatal stroke, non-fatal myocardial infarction, or cardiovascular death as the primary outcome. The key secondary composite outcome was all cause death or hospitalization for unstable angina.

Key Dates

Start date
Jun 30, 2021
Status verified
Oct 2021
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin, Oral Tablet,10mg, od, 24 months.
  • Placebo Comparator: Placebo
    Placebo, Oral Tablet, od, 24 months.

Primary Outcome Measure

Subjects included in the composite endpoint of cardiovascular death, myocardial infarction or ischemic stroke (time to first or recurrent event). [ Time Frame: Up to 3 years ]

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