CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Description

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.

Conditions

Kidney Transplant; Complications, Diabetes Mellitus, Type 2

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Study Overview

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Study Details

Study overview

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.

CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Condition
Kidney Transplant; Complications
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 -
  • 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 -

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Myles Wolf, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2026-08