CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
CREST-KT is a single-center, double-blinded, randomized trial of empagliflozin therapy in 72 kidney transplant recipients with (n=36) and without type 2 diabetes (n=36). After evenly dividing patients by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.
Conditions:
🦠 Kidney Transplant; Complications 🦠 Diabetes Mellitus, Type 2
🗓️ Study Start (Actual) 25 July 2022
🗓️ Primary Completion (Estimated) 31 July 2026
✅ Study Completion (Estimated) August 2026
👥 Enrollment (Estimated) 72
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Equal to or greater than 12 months and up tp 60 months post kidney transplant
    • 2. Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening
    • 3. Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid
    • 4. Able to provide written consent -

    Exclusion Criteria:

    • 1. Type I diabetes
    • 2. Any other solid organ transplant
    • 3. Hemoglobin A1c greater than 12 %
    • 4. SGLT2i use at the time of enrollment
    • 5. Prior SGLT2i allergy or intolerance
    • 6. Pregnant or nursing at the time of enrollment
    • 7. History of antibody medicated rejection (AMR) or a Banff score greater than 2B for acute cellular rejection (ACR)
    • 8. Active anticoagulant use other than aspirin 81 mg for primary prevention of cardiovascular disease
    • 9. Known positive donor-specific antibodies prior to enrollment
    • 10. Uncircumcised men
    • 11. Greater than 2 urinary tract infections (UTI) over the 12 months prior to enrollment
    • 12. Any genital infections over the 12 months prior to enrollment -
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 May 2021
  • First Submitted that Met QC Criteria 24 May 2021
  • First Posted 28 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 February 2024
  • Last Update Posted 28 February 2024
  • Last Verified January 2024