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Clinical Trial Details

Trial ID: L4436
Source ID: NCT04906213
Associated Drug: Empagliflozin10mg Tab
Title: CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
Acronym: CREST-KT
Status: RECRUITING
Study Results: NO
Results:
Conditions: Kidney Transplant; Complications|Diabetes Mellitus, Type 2
Interventions: DRUG: Empagliflozin10Mg Tab|DRUG: Placebo
Outcome Measures: Primary: Change in kidney function as measured by eGFR, eGFR will be measured by blood test, 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, Baseline, 6 months, 9 months, 12 months and 18 months|Change in cardiac structure, Cardiac structure as measured by the 3D echocardiogram, Baseline, month 9 and month15|Change in blood insulin level, Blood insulin level will be determined lab values, Baseline, month 6 and month 18|Change in fasting blood sugar, Fasting Blood sugar will be determined lab values, Baseline, month 6 and month 18|Number of Urinary Tract infections, Data to be gathered from chart review and patient report, up to 18 months|Number of Genital infections, Data to be gathered from chart review and patient report, up to 18 months | Secondary: 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 | Other: Adverse events will be collected form the medical record and patient report, up to 18 months
Sponsor/Collaborators: Sponsor: Duke University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2022-07-25
Completion Date: 2026-08
Results First Posted:
Last Update Posted: 2025-03-10
Locations: Duke University Medical Center, Durham, North Carolina, 27710, United States
URL: https://clinicaltrials.gov/show/NCT04906213