Dapagliflozin in Living-Donor Kidney Transplant Recipients

Sponsor
University of Guadalajara
Study ID
NCT07555106
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Kidney Transplant
  • Kidney Transplant Failure

Eligibility Criteria

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

Interventions

  • Dapagliflozin (10mg Tab) — DRUG
    Dapagliflozin 10 mg orally once daily administered in addition to standard immunosuppressive therapy for 12 months.
  • Standard of Care — OTHER
    Participants receive standard immunosuppressive therapy and routine post-kidney transplant clinical management according to institutional protocols during the 12-month follow-up period.

Study Details

This randomized, open-label, single-center clinical trial aims to evaluate the effect of dapagliflozin on kidney allograft function in adult recipients of a first living-donor kidney transplant. Participants will be randomized to receive dapagliflozin 10 mg daily starting 4 weeks after transplantation or standard care without SGLT2 inhibitor therapy. The primary outcomes include changes in estimated glomerular filtration rate (eGFR) and albuminuria over 12 months. Secondary outcomes include kidney graft histology findings, oxidative stress biomarkers, cardiovascular parameters, infectious events, and kidney graft survival at 12 months.

Key Dates

Start date
Sep 15, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Dapagliflozin Group
    Dapagliflozin 10 mg orally once daily administered in addition to standard immunosuppressive therapy for 12 months.
  • Active Comparator: Control Group
    Standard post-transplant medical therapy without SGLT2 inhibitor.

Primary Outcome Measure

Change in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to 12 months ]

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