CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Pro00107752

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.

2022-07-25

2026-07-31

2026-08-01

Recruiting

Early phase I

72

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 -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled, double-blind, randomized clinical trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

2024-02-28