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Gene expression platform could revolutionize kidney transplant rejection diagnosis

NCT ID NCT07700563

Knowledge-focused Sponsor: Paris Translational Research Center for Organ Transplantation Source: ClinicalTrials.gov ↗

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study developed and tested HistoMX, an automated platform that analyzes gene activity in kidney transplant biopsy samples. Researchers used over 2,400 archived biopsies from adult kidney transplant recipients to see if the platform could accurately identify different types of transplant injury, such as rejection or viral infection. The goal is to provide doctors with a standardized molecular report alongside traditional microscope analysis, potentially leading to more precise and consistent diagnoses.

What this could mean

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

What this could lead to
If successful, this platform could provide faster, more standardized molecular insights to help doctors diagnose kidney transplant complications more accurately.
What could go wrong
This is an observational study using archived samples, not a clinical trial testing a treatment. The platform may not improve patient outcomes or be adopted in routine practice.

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

2,410 people

The number who actually took part.

Started

Jan 2004

Finished

May 2026

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

Post-transplant kidney allograft biopsies from adult recipients submitted for B-HOT transcriptomic profiling across eleven European and North American centers.

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: * Adult kidney transplant recipient, defined as age 18 years or older at transplantation * Post-transplant kidney allograft biopsy * Archived FFPE kidney allograft biopsy tissue is available and suitable for transcriptomic profiling * Biopsy submitted for B-HOT nCounter transcriptomic profiling * Available Banff reference pathology diagnosis * Available Banff lesion information required for endpoint definition * Sample meeting prespecified nCounter assay quality-control criteria Exclusion Criteria: * Recipient age \<18 years at transplantation * Multi-organ transplantation * Pre-transplant biopsy * Missing Banff reference pathology diagnosis * Failure of prespecified nCounter quality-control criteria * Missing or insufficient data required to define the relevant reference endpoint

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Conditions

The condition(s) this trial relates to.

acute transplant rejection BK-virus nephropathy chronic renal failure syndrome end stage renal failure transplant rejection

As listed by the trial registrant

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

Antibody-mediated rejection BK virus nephropathy Chronic kidney disease (CKD) stage 5 Kidney allograft injury Kidney transplant Rejection of renal transplant T-cell mediated rejection

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