Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

Beijing Tsinghua Chang Gung Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: Tacrolimus Sustained-release Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06147648

23163-4-01

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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; ....

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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352 participants in 1 patient group

Experimental: Single arm observational registry study Drug: Tacrolimus Sustained-release Capsules

Experimental group

Description:

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)

Treatment:

Drug: Tacrolimus Sustained-release Capsules