CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Launched by DUKE UNIVERSITY · May 24, 2021

Keywords

ClinConnect Summary

The CREST-KT trial is studying the effects of a medication called empagliflozin on kidney transplant recipients, particularly looking at how it might help those with and without type 2 diabetes. This trial involves 72 participants who are at least one year post-transplant and are generally healthy, with a specific kidney function level. Participants will be randomly assigned to receive either empagliflozin or a placebo (a dummy pill that has no medication) to see how the drug affects their heart and kidney health.

To be eligible for this trial, participants must be between 12 to 60 months after their kidney transplant, have a certain level of kidney function, and be on standard medications to prevent organ rejection. Participants can expect to be part of a study that might help improve care for kidney transplant patients. It's important to note that those with type 1 diabetes, certain infections, or those who are pregnant cannot participate. This trial is currently looking for volunteers and aims to gather valuable information about managing health after a kidney transplant.

Gender

ALL

Eligibility 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 -