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NOT YET RECRUITING
NCT07815938

Immune Monitoring-Guided Individualized Tacrolimus Therapy in Renal Transplant Recipients: An Observational Study and PK/PD Modeling

Sponsor: Zhongnan Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-09-01

Completion Date

2028-12-31

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

OTHER

No interventional treatment, only observational data collection without clinical drug adjustment

No interventional treatment, only observational data collection without clinical drug adjustment