Empagliflozin Treatment in Kidney Transplant Recipients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorVA Office of Research and Development

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

264 Participants
are divided into 1 treatment group

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