Rejection after pediatric liver transplantation
Conditions
Interventions
Conventional Dosing Group:PopPK-ML Integrated Model-Guided Dosing
Model-Guided Dosing Group:PopPK-ML Integrated Model-Guided Dosing
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1.Infants and young children (aged 0-3 years) undergoing primary liver transplantation; 2.Tacrolimus was prescribed as the primary immunosuppressive regimen for at least one year postoperatively; 3.Legal guardians voluntarily provide written informed consent; 4.Patients were expected to complete at least one year of regular postoperative follow-up.
Exclusion criteria
Exclusion criteria: 1.Having received multi-organ transplantation (e.g., combined liver-kidney transplantation); 2.Patients with graft failure or requirement for re-transplantation due to severe complications within 3 months postoperatively; 3.Hypersensitivity to TAC or its excipients; 4.Legal guardians who refuse to participate in the study or are unable/unwilling to comply with follow-up visits, data collection, or medication records due to personal reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients Achieving Tacrolimus Target Concentration (8-12 ng/mL) within 3 Months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first achievement of target concentration postoperatively;1-Year composite endpoint incidence (acute rejection/graft loss/patient death/TAC-related neurotoxicity);Target attainment rates of tacrolimus concentrations at postoperative days (POD) 7, 14 and 30;Incidence and severity of biopsy-proven acute rejection within the first postoperative year; | — |
Countries
China
Contacts
Public ContactFang Chen
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed