Can a diabetes drug protect transplanted kidneys? new study aims to find out
NCT ID NCT06013865
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether empagliflozin (Jardiance), a drug used for diabetes and chronic kidney disease, is safe for people who have received a kidney transplant. Researchers will enroll 264 veterans and monitor for side effects like infections and changes in kidney function. If safe, it could help prevent heart and kidney problems in transplant recipients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin (Jardiance)
- What this could lead to
- If successful, this could show that empagliflozin is safe for kidney transplant patients, potentially reducing heart and kidney complications.
- What could go wrong
- This is a small, early-phase safety study, so results may not confirm effectiveness. There are concerns about increased infections and effects on graft function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 264 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 eGFR must be 20mL/min/1.73m2 to 59mL/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). Exclusion Criteria: 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol 2. History of prior pancreas transplant 3. 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 4. Uncontrolled type 2 diabetes mellitus with most recent A1C\>12% 5. History of \>2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year. 6. Use of SGLT2i within 90 days 7. Documented allergy to SGLT2i 8. History of Type I diabetes mellitus 9. History of diabetic ketoacidosis 10. Indwelling foley catheter or urinary diversion 11. Acute rejection in the prior 3 months 12. Acute MACE event within 3 months of the study 13. Severe congestive heart failure (NYHA functional class III or higher) 14. Active mucocutaneous mycotic infection of the groin or external genitalia. 15. History of amputation due to peripheral vascular disease and/or diabetic foot ulcers within prior year 16. History of malignancy except non-melanoma skin cancer within 2 years of screening 17. Known of active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease) 18. HIV infected subjects, including those who are well controlled on anti-retrovirals 19. Recent (within 6 months) Positive Hep B PCR or active disease 20. Hepatitis C virus antibody positive (HCVAb+) subjects who have failed to demonstrate sustained viral remission for more than 12 weeks (after anti-viral treatment) 21. Active pregnancy in a female transplant recipient 22. A condition, in the eyes of the investigator, that precludes inclusion into the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Edward Hines Jr. VA Hospital, Hines, IL
RECRUITINGHines, Illinois, 60141-3030, United States
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Iowa City VA Health Care System, Iowa City, IA
RECRUITINGIowa City, Iowa, 52246-2292, United States
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Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
RECRUITINGOmaha, Nebraska, 68105-1850, United States
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Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
RECRUITINGNashville, Tennessee, 37212-2637, United States
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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITINGPittsburgh, Pennsylvania, 15240, United States
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