CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Phase 2TerminatedNCT04906213

Duke University20 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Kidney Transplant; Complications Diabetes Mellitus, Type 2

Interventions

Empagliflozin10Mg TabDRUG

Empagliflozin10 Mg daily or placebo daily for 18 months

PlaceboDRUG

10Mg Placebo Tab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 -

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in kidney function as measured by eGFR

eGFR will be measured by blood test

Time frame: Baseline, 6 months, 9 months, 12 months and 18 months

Change in kidney function as measured by albuminuria

Albuminuria will be measured by urine Albumin/Creatinine Ratio

Time frame: Baseline, 6 months, 9 months, 12 months and 18 months

Change in cardiac structure

Cardiac structure as measured by the 3D echocardiogram

Time frame: Baseline, month 9 and month15

Change in blood insulin level

Blood insulin level will be determined lab values

Time frame: Baseline, month 6 and month 18

Change in fasting blood sugar

Fasting Blood sugar will be determined lab values

Time frame: Baseline, month 6 and month 18

Number of Urinary Tract infections

Data to be gathered from chart review and patient report

Time frame: up to 18 months

Number of Genital infections

Data to be gathered from chart review and patient report

Time frame: up to 18 months

Secondary Outcomes

Change in kidney biopsy as measured by percentage of interstitial fibrosis

Time frame: Baseline and 6 months

Changes in Hemoglobin A1C as measured by blood work

Data from ClinicalTrials.gov

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