TERMINATED

CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Conditions

Kidney Transplant; Complications Diabetes Mellitus, Type 2 Post operative kidney transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Quick Facts

Study Start:2022-07-25

Study Completion:2026-01-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04906213

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 -

Inclusion Criteria

Exclusion 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 -

Contacts and Locations

Principal Investigator

Myles Wolf, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Myles Wolf, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-25

Study Completion Date2026-01-22

Study Record Updates

Study Start Date2022-07-25

Study Completion Date2026-01-22

Terms related to this study

Keywords Provided by Researchers

Post operative kidney transplant

Additional Relevant MeSH Terms

Kidney Transplant; Complications
Diabetes Mellitus, Type 2