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Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients

NCT04965935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-03-20

No results posted yet for this study

Summary

This study will be a randomized, double-blind, placebo-controlled clinical trial comparing the SGLT2 inhibitor dapagliflozin to placebo in 52 kidney transplant recipients (KTR) with or without pre-existing type 2 diabetes (T2D) or post-transplant diabetes mellitus (PTDM). The primary outcome of the trial is to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR.

Conditions

  • Kidney Transplant Recipients
  • Post-transplant Diabetes Mellitus
  • Type 2 Diabetes

Interventions

DRUG

Dapagliflozin 10 MG Oral Tablet

Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.

DRUG

Placebo Matching Dapagliflozin Oral Tablet

Placebo will be administered for 12 weeks.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Sunita KS Singh, MD MSc FRCPC · University Health Network, Toronto General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965935 on ClinicalTrials.gov