This study aims to resolve the clinical limitation that therapeutic drug monitoring (TDM) alone cannot accurately reflect the net immune status after kidney transplantation. Within 12 months post-transplantation, we will systematically characterize dynamic trajectories of biomarkers including TTV DNA load, lymphocyte subsets and cytokines, and quantify their correlations with BK virus infection (over-immunosuppression) and acute rejection (insufficient immunosuppression). By integrating tacrolimus pharmacokinetics (PK), pharmacogenomics and immune monitoring indicators, a population pharmacokinetic-pharmacodynamic (PopPK/PD) model will be established to provide evidence supporting the paradigm shift from concentration-based dosing to immune effect-guided precision dosing.
Study Type
OBSERVATIONAL
Enrollment
50
No interventional treatment, only observational data collection without clinical drug adjustment
Tacrolimus trough blood concentration
Time frame: Routine follow-up time points within 12 months after kidney transplantation (1 week, 2 weeks, 1 month, monthly from 2 to 12 months post-operation)
Immune monitoring biomarkers (TTV DNA load, lymphocyte subsets, cytokines)
Time frame: Collected simultaneously with tacrolimus sampling at all follow-up visits within 12 months post-transplantation
BK virus infection, acute cellular rejection
Time frame: Recorded and confirmed on the day of event occurrence during 12-month full follow-up
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