Status:
ACTIVE_NOT_RECRUITING
CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
Lead Sponsor:
Duke University
Conditions:
Kidney Transplant; Complications
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
A screening visit will occur at which time an informed consent will be obtained, and eligibility determined. Women of childbearing potential will have a serum pregnancy test performed. This will be fo...
Eligibility Criteria
Inclusion
- Equal to or greater than 12 months and up tp 60 months post kidney transplant
- Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening
- Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid
- Able to provide written consent -
Exclusion
- Type I diabetes
- Any other solid organ transplant
- Hemoglobin A1c greater than 12 %
- SGLT2i use at the time of enrollment
- Prior SGLT2i allergy or intolerance
- Pregnant or nursing at the time of enrollment
- History of antibody medicated rejection (AMR) or a Banff score greater than 2B for acute cellular rejection (ACR)
- Active anticoagulant use other than aspirin 81 mg for primary prevention of cardiovascular disease
- Known positive donor-specific antibodies prior to enrollment
- Uncircumcised men
- Greater than 2 urinary tract infections (UTI) over the 12 months prior to enrollment
- Any genital infections over the 12 months prior to enrollment -
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04906213
Start Date
July 25 2022
End Date
January 23 2026
Last Update
December 17 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710