Actively Recruiting
Empagliflozin Treatment in Kidney Transplant Recipients
Led by VA Office of Research and Development · Updated on 2026-04-21
264
Participants Needed
5
Research Sites
312 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
I
Iowa City VA Health Care System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Empagliflozin Treatment in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old, any gender or race
- Able to understand and give consent
- Received a primary or secondary kidney transplant at least 3 months ago
- For participants with type 2 diabetes or post-transplant diabetes: kidney function with eGFR 30 to 59 mL/min/1.73m2 or eGFR 60 with urine albumin:creatinine ratio 30 mg/g (or protein:creatinine 100 mg/g)
- For participants without diabetes: kidney function with eGFR 20 to 59 mL/min/1.73m2 or eGFR 60 with urine albumin:creatinine ratio 30 mg/g (or protein:creatinine 100 mg/g)
You will not qualify if you...
- Unable or unwilling to provide written consent or follow study procedures
- History of prior pancreas transplant
- For those with diabetes: eGFR under 30 mL/min/1.73m2; for those without diabetes: eGFR under 20 mL/min/1.73m2; or eGFR dropping by 5 mL/min/1.73m2 per year
- Uncontrolled type 2 diabetes with A1C over 12%
- More than 2 urinary tract infections per year, or UTI requiring hospital admission or urosepsis in the past year
- Use of SGLT2 inhibitors within last 90 days
- Allergy to SGLT2 inhibitors
- History of type 1 diabetes or diabetic ketoacidosis
- Having an indwelling Foley catheter or urinary diversion
- Acute rejection of kidney transplant in last 3 months
- Acute major cardiovascular event in last 3 months
- Severe congestive heart failure (NYHA class III or higher)
- Active fungal infection of groin or external genitalia
- Amputation due to peripheral vascular disease or diabetic foot ulcers in past year
- History of cancer except non-melanoma skin cancer within 2 years
- Current active viral, fungal, mycobacterial, or other infections
- HIV infection
- Recent positive Hepatitis B test or active disease within 6 months
- Hepatitis C positive without sustained viral remission after treatment
- Active pregnancy
- Any condition that investigator believes prevents safe participation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Actively Recruiting
2
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2292
Actively Recruiting
3
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Actively Recruiting
4
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Actively Recruiting
5
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Actively Recruiting
Research Team
R
Roslyn B Mannon, MD
CONTACT
R
Ramesh K Ramalingam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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