Clinical trial NCT06147648: Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.
Official title: Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Liver Transplantation
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 18 years old and above
2. 3 months after liver transplantation;
3. Stable use of immediate-release tacrolimus for at least one month before enrollment in the study;
4. The serum levels of aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] were within the normal range; ....

Exclusion Criteria

1. Multi-organ combined transplantation or multiple liver transplantation;
2. Multiple organ recipients or those who have previously transplanted any organs；
3. Adjuvant liver transplantation or use of bioartificial liver therapy;
4. Prior to joining the group, they had received treatment with immune checkpoint (ICIs);
5. Participation in any other clinical study within 3 months prior to enrollment;
6. Use of tacrolimus sustained release capsules before enrollment;
7. Tacrolimus trough concentration lower than 5 ng/ml at the time of screening;
8. Acute rejection occurred within one month prior to enrollment; ....

Primary outcomes:
measure: Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion
timeFrame: within 3, 6, and 12 months after conversion
Secondary outcomes:
measure: Graft survival rate and patient survival rate at 12 months after conversion
timeFrame: 12 months after conversion
measure: The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules;
timeFrame: 3 months after liver transplantation
measure: Incidence of infection (viral, bacterial and fungal) at 12 months after conversion;
timeFrame: 12 months after conversion;
measure: Observe the serum aspartate aminotransferase (AST) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
timeFrame: within 3,6,12 months after conversion
measure: Observe the serum alanine aminotransferase (ALT) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
timeFrame: within 3,6,12 months after conversion
measure: Observe the creatinine clearance rate of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
timeFrame: within 3,6,12 months after conversion
Other outcomes:
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