NCT07877103Not yet recruitingPhase 4
Study on the Safety and Efficacy of a Time-of-Day-Based Individualized Tacrolimus Dosing Regimen in Kidney Transplant Recipients
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 25 Oct 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07877103
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 25 Oct 2026 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Pregnant women, or women of childbearing potential who plan to become pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.