Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

• Sponsor: Beijing Tsinghua Chang Gung Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06147648
• Collaborator: (none)
• Enrollment: 352
• Arm: 1
• Anticipated Duration (Months): 31.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation	Drug: Tacrolimus Sustained-release Capsules	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 352 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jul 30, 2025
• Anticipated Study Completion Date: Jul 30, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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)

Drug: Tacrolimus Sustained-release Capsules; Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation

Outcome Measures

Primary Outcome Measures

1. Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion [within 3, 6, and 12 months after conversion]

Secondary Outcome Measures

1. Graft survival rate and patient survival rate at 12 months after conversion [12 months after conversion]

2. The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules; [3 months after liver transplantation]

3. Incidence of infection (viral, bacterial and fungal) at 12 months after conversion; [12 months after conversion;]

4. Observe the serum aspartate aminotransferase (AST) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus. [within 3,6,12 months after conversion]

5. Observe the serum alanine aminotransferase (ALT) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus. [within 3,6,12 months after conversion]

6. Observe the creatinine clearance rate of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus. [within 3,6,12 months after conversion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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; ….

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Beijing Tsinghua Chang Gung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: QIAN LU, professor, Beijing Tsinghua Chang Gung Hospital
• ClinicalTrials.gov Identifier: NCT06147648
• Other Study ID Numbers: 23163-4-01
• First Posted: Nov 27, 2023
• Last Update Posted: Nov 27, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tacrolimus

Study Results

No Results Posted as of Nov 27, 2023