Blood test may take the guesswork out of transplant drug dosing
NCT ID NCT07718633
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 750 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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: * 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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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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- Can smarter monitoring of transplant drugs prevent rejection in kids?
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