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AI takes on kidney transplant rejection in new pilot trial

NCT ID NCT05432765

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests whether an AI-based system can help doctors choose the right doses of immunosuppressant drugs for kidney transplant patients. The goal is to protect the new kidney from damage and rejection. The study will enroll 34 adults who have received a deceased donor kidney transplant and need the drug tacrolimus. Researchers will measure changes in kidney scarring and function over 15 months.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 34 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

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 to 99 years

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: * Adult (18 years of age or older) patients with end-stage renal disease (ESRD) * Recipient of a first or subsequent deceased donor kidney transplant * Clinical indication to receive tacrolimus as the primary immunosuppression * Willing and able to provide written informed consent to participate Exclusion Criteria: * Recipients of transplanted organs other than kidney * Recipients of a transplant from a monozygotic (identical) sibling * Human Leukocyte Antigen (HLA)-identical donor (zero out of six antigen mismatch donor) * Recipient of third or more transplant * Current or historical panel reactive antibodies of more than 50% * Blood Type (ABO) incompatibility or known moderate or strong donor specific antibodies * De novo or recurrent glomerulonephritis on 3-month biopsy * Lupus nephritis on 3-month biopsy * Focal segmental glomerulosclerosis on 3-month biopsy * BK polyomavirus nephropathy in current or prior transplant * Recipient of a bone marrow transplant * Recipient who is pregnant * Enrollment in a competing trial that would interfere with selection or alteration of immunosuppression * Inability to follow up with transplant center for up to 15 months after transplantation * Anticipated major surgery during the time of planned study * Major medical illness with life expectancy less than 15 months * Suspicion of noncompliance * Anticipated relocation to a location that would not allow follow up at local center in the next 18 months * Inability to tolerate normal range levels of tacrolimus

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Conditions

The condition(s) this trial relates to.

end stage renal failure transplant rejection prevention target

As listed by the trial registrant

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

Kidney transplant rejection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • University of Florida Health Shands

    Gainesville, Florida, 32610, United States

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