Diabetes Mellitus, Type 2, Kidney Transplant; Complications
Conditions
Keywords
Post operative kidney transplant
Brief summary
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.
Detailed description
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.
Interventions
Empagliflozin10 Mg daily or placebo daily for 18 months
DRUGPlacebo
10Mg Placebo Tab
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Placebo-controlled, double-blind, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in kidney function as measured by albuminuria | Baseline, 6 months, 9 months, 12 months and 18 months | Albuminuria will be measured by urine Albumin/Creatinine Ratio |
| Change in cardiac structure | Baseline, month 9 and month15 | Cardiac structure as measured by the 3D echocardiogram |
| Change in kidney function as measured by eGFR | Baseline, 6 months, 9 months, 12 months and 18 months | eGFR will be measured by blood test |
| Change in blood insulin level | Baseline, month 6 and month 18 | Blood insulin level will be determined lab values |
| Change in fasting blood sugar | Baseline, month 6 and month 18 | Fasting Blood sugar will be determined lab values |
| Number of Urinary Tract infections | up to 18 months | Data to be gathered from chart review and patient report |
| Number of Genital infections | up to 18 months | Data to be gathered from chart review and patient report |
Secondary
| Measure | Time frame |
|---|---|
| Change in kidney biopsy as measured by percentage of interstitial fibrosis | Baseline and 6 months |
| Changes in Hemoglobin A1C as measured by blood work | Baseline, Months 3,6,9,12,15 and 18 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMyles Wolf, MD
Duke University
Outcome results
None listed