CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

Phase 2

Recruiting

• Conditions: Kidney Transplant; Complications; Diabetes Mellitus, Type 2
• Interventions: Drug: Empagliflozin10Mg Tab; Drug: Placebo

• Registration Number: NCT04906213
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-28
• Study Start: 2022-07-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-07-31
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 -

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I: With Type II Diabetes	Empagliflozin10Mg Tab	Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.
Arm 2: Without Diabetes	Empagliflozin10Mg Tab	Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo
Arm 2: Without Diabetes	Placebo	Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo
Arm I: With Type II Diabetes	Placebo	Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.

Primary Outcome Measures

Name	Time	Method
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 fasting blood sugar	Baseline, month 6 and month 18	Fasting Blood sugar will be determined lab values
Number of Genital infections	up to 18 months	Data to be gathered from chart review and patient report
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 blood insulin level	Baseline, month 6 and month 18	Blood insulin level will be determined lab values
Change in cardiac structure	Baseline, month 9 and month15	Cardiac structure as measured by the 3D echocardiogram
Number of Urinary Tract infections	up to 18 months	Data to be gathered from chart review and patient report

Secondary Outcome Measures

Name	Time	Method
Changes in Hemoglobin A1C as measured by blood work	Baseline, Months 3,6,9,12,15 and 18
Change in kidney biopsy as measured by percentage of interstitial fibrosis	Baseline and 6 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States