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

NCT04764097 | Withdrawn Phase 2 DMC

• 1 other identifier: TTSH-DECODED
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cardiovascular Diseases; End Stage Renal Disease

Keywords

Cardiovascular Outcomes; Renal Disease; Dapagliflozin; SGLT2 Inhibitor

Outcome Measures

Primary Outcomes (1)

• Subjects included in the composite endpoint of cardiovascular death, myocardial infarction or ischemic stroke (time to first or recurrent event).

  Data will be derived from 3 monthly telephone follow-up and 6monthly physical site visits and events are documented in eCRF

  Up to 3 years

Secondary Outcomes (1)

• Subjects included in the composite endpoint of all-cause death or hospitalization for unstable angina (time to first or recurrent event).

  Up to 3 years

Other Outcomes (1)

• Safety and tolerability will be assessed from overall adverse events, serious adverse events, adverse events of special interest

  Up to 3 years

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin, Oral Tablet,10mg, od, 24 months.

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo, Oral Tablet, od, 24 months.

Drug: Placebo

Interventions

Dapagliflozin DRUG

SGTL2 Inhibitor

Dapagliflozin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Failure, Chronic; Kidney Diseases

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded clinical trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Model Details: Randomised (1:1) to either Dapaglifozin 10mg or placebo.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share