Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

NCT ID: NCT06147648

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-07-30

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.

Conditions

Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

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)

Group Type: EXPERIMENTAL

Tacrolimus Sustained-release Capsules

Intervention Type: DRUG

Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation

Interventions

Tacrolimus Sustained-release Capsules

Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation

Intervention Type: DRUG

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; ….

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

QIAN LU

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

XUAN TONG, Doctor

Role: CONTACT

txa00853@btch.edu.cn

15901019879

Other Identifiers

23163-4-01

Identifier Type: -

Identifier Source: org_study_id