NCT04764097WithdrawnPhase 2/3
Dapagliflozin Effect on Cardiovascular Outcomes in Haemodialysis for End Stage Renal Disease
A Multi-centre, Randomised, Double-blind, Placebo-controlled Trial to Determine the Effect of Dapagliflozin 10mg Once Daily on Cardiovascular Outcomes in Haemodialysis for Patients With End Stage Renal Disease (ESRD)
Source: ClinicalTrials.gov · Last updated 21 Oct 2021
Reason given: Lack of funding and similar competing study being conducted in Europe.
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 18 Feb 2021
- Start date
- Jun 2021
- Primary completion date
- Jun 2025
- Lead sponsor
- Tan Tock Seng Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT04764097
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of an investigational drug or participating in another clinical trial involving an investigational drug.
Other illness
- Diagnosis of Type 1 diabetes mellitus.
- Any clinical condition that would jeopardize patient safety while participating in this clinical trial.
- Life limiting disease other than ESRD with life expectancy estimated to be less than 12 month.
Other
- Pregnant or planning pregnancy or breast-feeding patients.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.