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Study on the Safety and Efficacy of a Time-of-Day-Based Individualized Tacrolimus Dosing Regimen in Kidney Transplant Recipients
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
The goal of this clinical trial is to evaluate whether chronopharmacokinetic model-guided individualized unequal twice-daily tacrolimus dosing improves renal allograft function and reduces acute rejection in stable kidney transplant recipients. The main questions it aims to answer are: Does chrono-individualized tacrolimus dosing preserve graft renal function (eGFR) compared with conventional equal twice-daily dosing? Does chrono-individualized tacrolimus dosing lower the incidence of acute rejection in kidney transplant recipients? Researchers will compare recipients receiving chronopharmacokinetic-guided "low morning, high evening" individualized tacrolimus doses to recipients receiving conventional equal twice-daily tacrolimus doses to see if the chrono-individualized regimen improves renal function and reduces acute rejection risk. Participants will: Be randomly assigned to one of two tacrolimus dosing groups at a 1:1 ratio Receive routine immunosuppressive therapy and follow-up for 12 months Undergo blood sampling for tacrolimus concentration, calcineurin activity and multi-omics biomarker detection Complete regular clinical assessments of graft function, adverse events and rejection episodes
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-25
Completion Date
2028-12-30
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Chronotherapy-based individualized low-morning high-evening tacrolimus dosing
Dosing regimen with unequal morning-evening doses guided by a chronopharmacokinetic model
conventional dosing regimen
Conventional twice-daily equal-dose tacrolimus dosing regimen
Locations (1)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China