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AI may spot hidden kidney transplant rejection

NCT ID NCT07741552

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study is developing an artificial intelligence (AI) system to analyze kidney biopsy images from transplant patients. The goal is to see if AI can accurately tell apart different types of rejection, measure how much damage the kidney has, and predict if rejection might come back. Researchers will use leftover biopsy samples and medical records from about 1,000 patients, with no extra procedures or costs for participants. If the AI works well, it could help doctors make more precise treatment decisions and improve long-term outcomes for kidney 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
Artificial intelligence model analyzing kidney biopsy images and clinical data
What this could lead to
If successful, this AI tool could help doctors more accurately diagnose kidney transplant rejection, assess its severity, and predict the risk of recurrence, potentially improving long-term transplant outcomes.
What could go wrong
This is an observational study using existing biopsy samples, so it won't directly test a new treatment. The AI model's accuracy and reliability need to be validated, and it may not generalize to all patient populations or clinical settings.

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.

Participants

About 1,000 people

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

Started

Nov 2025

Expected to finish

Oct 2030

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.

Who is studied

This prospective observational study consecutively enrolls up to 1,000 eligible adult kidney transplant recipients aged 18-75 at The First Affiliated Hospital, Zhejiang University School of Medicine starting November 2025. Participants undergo clinically indicated renal allograft biopsy for monitoring or disease evaluation. The population includes cases with TCMR, ABMR, chronic rejection, polyomavirus nephropathy, recurrent primary renal disease and non-rejection controls. Only residual biopsy slides and anonymized clinical data are collected, with no additional invasive procedures. Subjects with poor specimens, incomplete data or unavailable follow-up records will be excluded. All participants provide informed consent and can withdraw freely. All identifiable information will be removed to protect privacy.

Ages

18 to 75 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: * Patients who received kidney transplantation and underwent clinically indicated renal allograft biopsy at The First Affiliated Hospital, Zhejiang University School of Medicine starting November 2025. * Age range from 18 to 75 years old. * Complete clinical baseline data, laboratory test records, medication history and pathological information available in electronic medical system. * Residual paraffin biopsy slides are available after routine pathological examination. * Voluntarily provide written informed consent for the use of residual pathological specimens and clinical data for research. Exclusion Criteria: * Poor-quality biopsy specimens including blurred staining, severe tissue damage or insufficient tissue volume which cannot support pathological image analysis. * Severe missing core clinical variables that cannot be supplemented via standardized data imputation. * Complicated with severe irreversible dysfunction of heart, liver, brain or other vital organs affecting long-term clinical follow-up data collection. * Unable to complete routine clinical follow-up, resulting in unavailable outcome data for recurrent rejection labeling. * Refuse to participate or withdraw informed consent.

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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.

Contacts and locations

Locations

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

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