Can immune monitoring replace drug levels for kidney transplant dosing?
NCT ID NCT07815938
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Kidney transplant recipients take tacrolimus to prevent rejection, but standard drug-level monitoring cannot show whether the immune system is over- or under-suppressed. This observational study follows 50 adults for 12 months after a first kidney transplant, measuring immune markers such as TTV DNA, lymphocyte subsets, and cytokines alongside tacrolimus levels. Researchers will build a model linking drug exposure, genetics, and immune activity to episodes of BK virus infection and acute rejection. The goal is to test whether immune monitoring can support more individualized dosing than concentration-based monitoring alone.
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 immune markers track rejection and infection better than drug levels, doctors could one day adjust tacrolimus doses based on each patient's immune response rather than blood concentration alone.
- What could go wrong
- This is a small observational study of 50 people at one center, so it cannot prove that immune-guided dosing works. The biomarker patterns it finds may not hold up in larger, more diverse groups.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
Patients receiving primary allogeneic kidney transplantation
- 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: 1. Aged 18-65 years, no gender restriction. 2. Patients receiving primary allogeneic kidney transplantation. 3. Maintenance immunosuppressive regimen based on tacrolimus after transplantation, with complete records of tacrolimus dosage, administration time and therapeutic drug monitoring data available. 4. Expected follow-up duration of at least 12 months at this center, and ability to complete scheduled blood and urine sample collection. 5. Subjects who fully understand the study protocol with good compliance, and provide written informed consent. Exclusion Criteria: 1. Combined multi-organ transplantation (e.g., combined liver-kidney transplantation). 2. ABO-incompatible transplantation or patients with high preformed donor-specific antibody (DSA) titers requiring special induction regimens due to high immunological risk. 3. Patients with active HIV, HCV or HBV infection, or preoperative severe active infection requiring systematic anti-infective therapy. 4. Patients with delayed graft function or graft loss within 1 week after surgery. 5. Patients with severe hepatic or renal dysfunction. 6. Participants enrolled in other interventional clinical trials. 7. Pregnant or breastfeeding women. 8. Other conditions judged inappropriate for study participation by investigators.
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How to take part
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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