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Can a diabetes drug protect transplanted kidneys? new study aims to find out

NCT ID NCT06013865

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 264 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Edward Hines Jr. VA Hospital, Hines, IL

    RECRUITING

    Hines, Illinois, 60141-3030, United States

  • Iowa City VA Health Care System, Iowa City, IA

    RECRUITING

    Iowa City, Iowa, 52246-2292, United States

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    RECRUITING

    Omaha, Nebraska, 68105-1850, United States

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    RECRUITING

    Nashville, Tennessee, 37212-2637, United States

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    RECRUITING

    Pittsburgh, Pennsylvania, 15240, United States

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