About this trial
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.
Eligibility criteria
Qualifiers
Adult (>18 years of age) male and female recipients (all races and ethnicities)
Subject must be able to understand and provide consent
Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant
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).
Disqualifiers
Inability or unwillingness of a participant to give written informed consent or comply with study protocol
History of prior pancreas transplant
CKD epi eGFR < 30 mL/min/1.73m2 for those with T2DM or < 20 mL/min/1.73m2 for those without T2DM or anyone with 5mL/min/1.73m2 fall in eGFR per year
Uncontrolled type 2 diabetes mellitus with most recent A1C>12%
Trial design
Treatments tested in this trial
- Empagliflozin
Treatment groups
Sponsors and collaborators
VA Office of Research and Development
Lead sponsor
Iowa City VA Health Care System
Collaborator
VA Pittsburgh Healthcare System
Collaborator
VA Tennessee Valley Health Care System
Collaborator
VA Hines Health Care
Collaborator