Time-of-day tacrolimus dosing for people with a kidney transplant
Tests a lower morning and higher evening tacrolimus dose in kidney transplant recipients.
Plain-language title generated from the registry record
Registry title: Study on the Safety and Efficacy of a Time-of-Day-Based Individualized Tacrolimus Dosing Regimen in Kidney Transplant Recipients
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07877103, who can take part
Where in China
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Guangzhou Medical University
- Trial code
- NCT07877103
- Record updated
- 16 October 2026
- Original description
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:Read full original descriptionShow less
Study on the Safety and Efficacy of a Time-of-Day-Based Individualized Tacrolimus Dosing Regimen in Kidney Transplant Recipients
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
Inclusion: Sex not restricted, age 18-70 years (inclusive); First living-donor or deceased-donor kidney transplantation; For deceased-donor transplantation, kidneys from donation after brain death (DBD); ABO blood type compatibility between donor and recipient; Negative panel reactive antibody (PRA) result within 6 months before surgery; Post-transplant immunosuppressive regimen must be the triple regimen of TAC + mycophenolate mofetil (MMF)/mycophenolate sodium (MPS) + glucocorticoids; More than 3 months after kidney transplantation, with stable graft function; Stable TAC dose regimen and Ctrough results, and stable concomitant medication regimen; Voluntarily participate in the clinical study, fully understand the study and voluntarily sign the informed consent form (ICF), and be able to complete all study procedures.
Exclusion: Multiple organ combined transplantation; History of prior organ transplantation other than the kidney; History of acute rejection after transplantation, or currently receiving treatment for acute rejection; Use of strong CYP3A inhibitors or strong inducers within 2 weeks before first dosing, or short-term use during the study; Evidence of active systemic or localized infection; Currently severe diarrhea, vomiting, active peptic ulcer, or other gastrointestinal diseases affecting TAC absorption; Allergy to TAC or its ingredients, or other contraindications precluding the use of TAC; Poor recipient compliance, or other conditions judged by the investigator to make the participant unsuitable for enrollment; Pregnant women, or women of childbearing potential who plan to become pregnant.