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New blood tests could spare transplant patients from painful biopsies

NCT ID NCT04855422

Knowledge-focused Sponsor: Montefiore Medical Center 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study is testing two blood tests, AlloSure and AlloMap, to see if they can detect organ rejection in people who have received a combined kidney and pancreas transplant. The goal is to find a less invasive way to monitor for rejection compared to the standard tissue biopsy. The study will follow 42 patients for up to three years after their transplant to see how well the blood tests work.

What this could mean

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

Active substance
Blood tests (AlloSure and AlloMap)
What this could lead to
If successful, these blood tests could help doctors detect organ rejection earlier and more safely in kidney-pancreas transplant patients, reducing the need for invasive biopsies.
What could go wrong
This is a small, early pilot study with only 42 participants. The tests may not prove accurate enough to replace biopsies, and results may not apply to all transplant patients.

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

41 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 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

SPK transplant recipients will be enrolled at the time of transplantation or anytime within 3 years after transplantation starting at least 1 month after transplantation. Patients will have blood samples drawn at the time enrollment and at 3, 6, 9, and 12 months after enrollment and at the time of clinically indicated kidney and/or pancreas transplant biopsy. If the patients had biopsy proven acute or chronic rejection, Allosure and Allomap test will be repeated at 2, 4, and 6 weeks after the diagnosis. For patients who developed BKV viremia, Allosure and Allomap test will be tested at the time of BKV viremia and will be repeated at 2, 4, and 6 weeks after BKV viremia.

Ages

18 years and older

Sex

Anyone

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: * Participant is willing and able to give informed consent for participation in the study * Male or Female, aged 18 years or above * SPK transplant recipients between 1 month and 3 years after transplantation Exclusion Criteria: * Previous history of solid organ transplantation * Pregnancy

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Conditions

The condition(s) this trial relates to.

Rejection, Psychology transplant rejection

As listed by the trial registrant

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

Transplant; complication, rejection

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.