Overview

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

Status:
Withdrawn
Trial end date:
2026-06-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tan Tock Seng Hospital
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.