An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)
VA Office of Research and Development
Summary
Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.
Description
Background: Kidney transplantation improves the health and quality of life for those veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult (\>18 years of age) male and female recipients (all races and ethnicities) 2. Subject must be able to understand and provide consent 3. Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant 4. For subjects with T2DM or post-transplant diabetes (PTDM), measured kidney function by CKD epi eGFR must be 30mL/min/1.73m2 to 59 mL/min/1.73m2 or CKD epi eGFR 60 mL/min/1.73m2 with urinary albumin:creatinine ratio 30 mg/g (or protein:creatinine 100 mg/g). 5. For subjects without T2DM or PTDM: measured kidney function by CKD epi e…
Interventions
- DrugEmpagliflozin
SGLT2 Inhibitor
Locations (5)
- Edward Hines Jr. VA Hospital, Hines, ILHines, Illinois
- Iowa City VA Health Care System, Iowa City, IAIowa City, Iowa
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmaha, Nebraska
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, Pennsylvania
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashville, Tennessee