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Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
  3. Start date: Dec 1, 2023 to Feb 1, 2024 Secondary endpoints: 3 to 7v3 Show 1 more changeShow less
    • Secondary endpoints: 3 to 7

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 30 words Secondary endpoints: details revised at 1 of 3 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 3 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.
Trial Details
NCT Number NCT06140537
Lead Sponsor University of Colorado, Denver
Conditions Kidney Transplant; Complications, Vascular Diseases, Diabetes
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov