Blood test may take the guesswork out of transplant drug dosing

NCT ID NCT07718633

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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
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When the status isn't known

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Status unknown
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First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial tests whether a blood test called Prospera can help doctors better adjust anti-rejection medications in people who have recently received a kidney transplant. The test measures DNA from the donor kidney to spot early signs of rejection or over-suppression. Researchers will compare outcomes like graft survival, kidney function, and side effects between patients managed with the test and those receiving standard care.

What this could mean

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

Active substance
a blood test called Prospera that measures donor-derived cell-free DNA to guide immunosuppressant dosing
What this could lead to
If successful, this blood test could help doctors personalize anti-rejection medication for kidney transplant recipients, potentially reducing organ rejection and drug side effects.
What could go wrong
The test may not improve outcomes over standard care, and false positives or negatives could lead to unnecessary or missed medication changes. As a diagnostic tool, it does not directly treat the disease.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 750 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: * Subjects received a kidney transplant in the prior 3 months. * Subjects receiving maintenance therapy consisting of tacrolimus, mycophenolate sodium or mycophenolate mofetil, and optionally corticosteroids, at the time of enrollment. * Subjects received induction therapy comprising IL2 receptor antagonist or thymoglobulin, or received no induction therapy. * 18 years of age or older at time of signing informed consent. * Able to read, understand and provide written informed consent, and willing and able to comply with the study requirements. If the subject is unable to sign the informed consent, a legally authorized representative (LAR) can consent on behalf of the subject. * Subjects are at the site standard-of-care MPA dosage Exclusion Criteria: * Concurrent multiple solid organ or tissue transplants. * History of a previous organ transplant (aside from present kidney transplant), or cellular transplant. * DSA Positive according to local protocol, including either pre-transplant DSA positivity and de novo DSA positivity. * Any prior dd-cfDNA results ≥1.0% or ≥78cp/mL after 28 days post-transplant. * ABO Incompatible donor. * A serious medical condition that may adversely affect ability to participate in the study (e.g, current diagnosis of cancer). * Pregnancy. * Received any induction therapy other than IL2 receptor antagonist or thymoglobulin. * Receiving any maintenance immunosuppression other than tacrolimus, mycophenolate sodium or mycophenolate mofetil, and prednisone. * Currently undergoing regular dialysis. * Considered high-risk at the time of enrollment, as per the treating physician. * Planned or ongoing use of other commercially available or investigational dd-cfDNA or blood-based gene expression profile assays for rejection surveillance, through randomization.

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