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Empagliflozin Treatment in Kidney Transplant Recipients

Study acronym: SEKTR
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 5 sites Eligibility criteria shortened, about 5 wordsv7 Show 1 more changeShow less
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 4 to 5 Eligibility criteria expanded, about 46 words · Study description expanded, about 6 words · Collaborators: 3 to 4v6 Show 3 more changesShow less
    • Eligibility criteria expanded, about 46 words
    • Study description expanded, about 6 words
    • Collaborators: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 1 of 4 sitesv5
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2024 to Apr 5, 2024 · Site details revised at 4 of 4 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2024 to Apr 5, 2024
    • Site details revised at 4 of 4 sites
  5. Phase: Not applicable to Phase 4v3
  6. Start date: Jan 1, 2024 to Apr 1, 2024 Primary completion date: Dec 31, 2029 to Mar 31, 2030 · Completion date: Dec 31, 2030 to Mar 31, 2030v2 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2029 to Mar 31, 2030
    • Completion date: Dec 31, 2030 to Mar 31, 2030
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.
Trial Details
NCT Number NCT06013865
Lead Sponsor VA Office of Research and Development
Collaborators: Iowa City VA Health Care System, VA Pittsburgh Healthcare System, VA Tennessee Valley Health Care System, VA Hines Health Care
Conditions Kidney Transplant, Chronic Kidney Disease
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov