CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

CREST-KT is a single-center, double-blinded, randomized trial of dapagliflozin 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 dapagliflozin 10mg versus placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

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 -