# An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)

> **NIH VA I01** · OMAHA VA  MEDICAL CENTER · 2024 · —

## Abstract

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. The goal of this submission is to examine the safety and efficacy of
SGLT2i therapy in veterans with KTRs and T2DM. Our hypothesis is treatment with SGLT2i will lead to
improvements in graft and cardiovascular outcomes in patients with T2DM, with acceptable side effect profile.
To test this hypothesis, we will execute a multicenter clinical trial at 4 VA medical centers, including 3 that serve
as primary kidney transplant programs. Our multidisciplinary research team includes transplant medical and
surgical expertise, diabetology, and informatics and statistical support familiar with VA data systems. In open
label fashion, we will treat eligible KTRs and comprehensively assess adverse and serious adverse event data,
as well as assess any untoward impacts on graft function and diabetes management. Secondly, we will utilize
VA data from the VINCI corporate data warehouse to develop a control cohort of veterans with KTRs and T2DM,
not treated with SGLT2i. We will utilize propensity score matching to reduce bias that may occur in observational
studies. With this strategy, we will further address the potential beneficial impact of SGLT2i treatment on
cardiovascular outcomes, as well as kidney disease progression in the transplanted kidney. We will also analyze
the cost impact of using this agent in this patient population, in terms of hospitalizations, unanticipated
procedures, and CKD management. These studies will provide new information to the transplant community for
both veteran and non-veteran alike, with a detailed assessment of safety and feasibility of this agent class using
a pragmatic approach to transplant care. These results will translate into an opportunity to mitigate late graft loss
in this patient population, and a potential breakthrough in clinical care that to date has been unrecognized.

## Key facts

- **NIH application ID:** 10691581
- **Project number:** 1I01CX002666-01
- **Recipient organization:** OMAHA VA  MEDICAL CENTER
- **Principal Investigator:** ROSLYN B MANNON
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2024-01-01 → 2029-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10691581

## Citation

> US National Institutes of Health, RePORTER application 10691581, An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR) (1I01CX002666-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10691581. Licensed CC0.

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