CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
Who is this study for? Kidney transplant recipients
What treatments are being studied? Empagliflozin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Equal to or greater than 12 months and up tp 60 months post kidney transplant
• Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening
• Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid
• Able to provide written consent -
Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Rachael Abuin, BSN
rachael.abuin@duke.edu
919-684 8136
Backup
Daniel Edmonston, MD
daniel.edmonston@duke.edu
919-668-4596
Time Frame
Start Date: 2022-07-25
Estimated Completion Date: 2026-08
Participants
Target number of participants: 72
Treatments
Active_comparator: Arm I: With Type II Diabetes
Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.
Active_comparator: Arm 2: Without Diabetes
Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo
Related Therapeutic Areas
Sponsors
Leads: Duke University