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NOT YET RECRUITING
NCT07877103
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Chronotherapy-based individualized low-morning high-evening tacrolimus dosing

Dosing regimen with unequal morning-evening doses guided by a chronopharmacokinetic model

DRUG

conventional dosing regimen

Conventional twice-daily equal-dose tacrolimus dosing regimen

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China