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Blood test may forecast kidney transplant rejection before it happens

NCT ID NCT05084768

Diagnosis Sponsor: Loma Linda University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study is testing whether a combination of two blood markers can predict acute rejection and graft failure after a kidney transplant. The markers are donor-derived cell-free DNA (dd-cfDNA), which rises before rejection, and a type of regulatory T cell (HLA-DR+TNFR2+) that is reduced in recipients who reject. Researchers will measure these markers in 150 kidney transplant recipients at regular intervals for the first 6 months after transplant, then check how well they predict biopsy-proven rejection and 1-year graft function. If the markers prove accurate, they could help doctors identify at-risk patients early and tailor immunosuppression to each person.

What this could mean

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

Active substance
Donor-derived cell-free DNA and HLA-DR+TNFR2+ regulatory T cells (blood biomarkers)
What this could lead to
If successful, this could lead to a simple blood test that predicts kidney transplant rejection early, allowing doctors to personalize immunosuppression and improve long-term graft survival.
What could go wrong
This is an observational study, not a treatment trial. The biomarkers may not prove accurate enough in larger, diverse populations, and the results may not change clinical practice without further validation.

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 150 people

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

Started

Dec 2020

Expected to finish

Oct 2026

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

Adult kidney transplant candidates/recipients

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 candidates/recipients Exclusion Criteria: * Age less than 18 * Multi-organ transplants * Kidney transplant candidates/recipients with HIV * Kidney transplant candidates/recipients with HCV

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Conditions

The condition(s) this trial relates to.

acute transplant rejection

As listed by the trial registrant

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

Acute rejection of renal transplant Graft failure

How to take part

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  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

  • Loma Linda University Health

    RECRUITING

    Loma Linda, California, 92354, United States

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