Status:

WITHDRAWN

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

Lead Sponsor:

Tan Tock Seng Hospital

Conditions:

Cardiovascular Diseases

End Stage Renal Disease

Eligibility:

All Genders

21+ years

Phase:

PHASE2

PHASE3

Brief Summary

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 c...

Detailed Description

Cardiovascular disease accounts for more than 50% of end-stage renal disease (ESRD) deaths. The reported cardiovascular death rates in patients receiving dialysis are substantially higher than in the ...

Eligibility Criteria

Inclusion

  • Provision of informed consent prior to any study specific procedures.
  • Female or male aged ≥ 21 years.
  • Undergoing haemodialysis for end stage renal disease regardless of cause and previous cardiac events.

Exclusion

  • Diagnosis of Type 1 diabetes mellitus.
  • Pregnant or planning pregnancy or breast-feeding patients.
  • Any clinical condition that would jeopardize patient safety while participating in this clinical trial.
  • Intake of an investigational drug or participating in another clinical trial involving an investigational drug.
  • Life limiting disease other than ESRD with life expectancy estimated to be less than 12 month.

Key Trial Info

Start Date :

June 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2026

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04764097

Start Date

June 1 2021

End Date

June 1 2026

Last Update

October 21 2021

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