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

ConditionTransplant Recipient (Kidney)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhongnan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-65 years, no gender restriction.

Patients receiving primary allogeneic kidney transplantation.

Maintenance immunosuppressive regimen based on tacrolimus after transplantation, with complete records of tacrolimus dosage, administration time and therapeutic drug monitoring data available.

Expected follow-up duration of at least 12 months at this center, and ability to complete scheduled blood and urine sample collection.

Disqualifiers

Combined multi-organ transplantation (e.g., combined liver-kidney transplantation).

ABO-incompatible transplantation or patients with high preformed donor-specific antibody (DSA) titers requiring special induction regimens due to high immunological risk.

Patients with active HIV, HCV or HBV infection, or preoperative severe active infection requiring systematic anti-infective therapy.

Patients with delayed graft function or graft loss within 1 week after surgery.

Trial population

Patients receiving primary allogeneic kidney transplantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

BK virus infection, acute cellular rejection

Time frame
Recorded and confirmed on the day of event occurrence during 12-month full follow-up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongnan Hospital

Lead sponsor

Fudan University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: