A Phase 4 interventional study of Tacrolimus Sustained-release Capsules in Liver Transplantation, sponsored by Beijing Tsinghua Chang Gung Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Phase 4, Interventional, and Prevention
Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Moreover, there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients. Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period. At the same time, patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery, and the proportion of drug conversion needs to be further explored.
This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation. Furthermore, it seeks to investigate the impact of this conversion on indicators such as liver function, kidney function, metabolic disease incidence, and infection incidence in patients.
Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Drug: Tacrolimus Sustained-release Capsules After liver transplantation, immediate-release tacrolimus was administered for acute rejection prevention, and after 3 months, it was converted into tacrolimus sustained-release capsules in a ratio of 1:1 to 1:1.2; (The specific medication plan is decided by the clinician according to the actual situation)
Drug: Tacrolimus Sustained-release Capsules
Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation
Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion
Time frame: within 3, 6, and 12 months after conversion
Graft survival rate and patient survival rate at 12 months after conversion
Time frame: 12 months after conversion
The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules;
Time frame: 3 months after liver transplantation
Incidence of infection (viral, bacterial and fungal) at 12 months after conversion;
Time frame: 12 months after conversion;
Observe the serum aspartate aminotransferase (AST) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Time frame: within 3,6,12 months after conversion
Observe the serum alanine aminotransferase (ALT) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Time frame: within 3,6,12 months after conversion
Observe the creatinine clearance rate of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Time frame: within 3,6,12 months after conversion
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Beijing Tsinghua Chang Gung Hospital