CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Last updated: March 5, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Treatment

Empagliflozin10Mg Tab

Placebo

Clinical Study ID

NCT04906213
Pro00107752
  • Ages > 18
  • All Genders

Study 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 by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.

Eligibility Criteria

Inclusion

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/1.73msquared at screening

  3. Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetilor Sodium and a glucocorticoid

  4. Able to provide written consent -

Exclusion

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 foracute cellular rejection (ACR)

  8. Active anticoagulant use other than aspirin 81 mg for primary prevention ofcardiovascular 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 -

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Empagliflozin10Mg Tab
Phase: 2
Study Start date:
July 25, 2022
Estimated Completion Date:
August 31, 2026

Study 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 followed by a baseline visit. A renal biopsy and a 3D echocardiogram will be performed. At the next visit randomization will be performed and the subjects will receive their study medication, either empagliflozin or a placebo. Following the randomization visit the subject will return every 3 months (visits 2-7) for a total of 6 visits spanning 18 months. At each visit vital signs and weight will be taken. Other procedures include labs drawn for hematology, basic chemistry, coagulation, Glycated hemoglobin and serum insulin. A 3 D echocardiogram is repeated on Visits 4 and 6. A renal biopsy is repeated on Visit 3.

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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