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Could a diabetes drug shield heart transplant patients from kidney failure?

NCT ID NCT05321706

Disease control Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests whether dapagliflozin (Farxiga), a drug originally developed for diabetes, can protect kidney function in people who have received a heart transplant. Kidney failure is a common and serious complication after heart transplant. The study involves 430 participants who will take either dapagliflozin or a placebo daily for one year, with researchers measuring changes in kidney function and other health outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin (Farxiga)
What this could lead to
If it works, this could offer a new way to protect kidney function in heart transplant patients, reducing the risk of kidney failure and improving long-term outcomes.
What could go wrong
This is a Phase 3 trial, but SGLT2 inhibitors have not been tested in heart transplant recipients before, so unexpected side effects or lack of benefit are possible. The trial lasts one year, so long-term effects are not yet known.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 430 people

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

Started

Jun 2022

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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. Heart transplant recipient ≥ 1 year after heart transplant. 2. Age ≥ 18 years Exclusion Criteria: 1. Contraindications to study medication. 2. Estimated GFR \< 25 ml/min/m2 3. Type I diabetes 4. Severe liver failure (Child-Pugh's score C) 5. Life expectancy reduced to \< 2 years as judged by the investigator 6. Unresolved malignant disease 7. Failure to obtain written informed consent 8. SGL2 inhibitor treatment over the last month 9. Pregnancy 10. Breast-feeding 11. Woman of child-bearing potential who is not willing to use a highly effective method of birth control

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Conditions

The condition(s) this trial relates to.

kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart transplant failure Kidney failure

Contacts and locations

Locations

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Karolinska University Hospital

    Stockholm, Sweden

  • Oslo University Hospital, Rikshospitalet

    Oslo, Oslo, 0372, Norway

  • Skane University Hospital

    Lund, 22185, Sweden

  • University Medical Center Groningen

    Groningen, Netherlands

  • University Medical Center Utrecht

    Utrecht, 3584, Netherlands

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