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

Sponsor
University Health Network, Toronto
Study ID
NCT04965935
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 15, 2021
Status verified
Apr 2026
Primary completion
Aug 30, 2024
Completion
Aug 30, 2024

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin Tablets
    Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks.
  • Placebo Comparator: Placebo Matching Dapagliflozin Tablets
    Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks.

Primary Outcome Measure

Systolic Blood Pressure (SBP) [ Time Frame: Change from baseline SBP at 12 weeks of treatment ]

Related coverage on Hipa.ai

Related Studies