AI may spot hidden kidney transplant rejection
NCT ID NCT07741552
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
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- 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: * 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
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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Other studies related to the condition(s) this trial covers.
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