Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

Liver Transplantation Clinical Trial

Official title:

Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147648
• Other study ID #: 23163-4-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: November 2023
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: XUAN TONG, Doctor
• Phone: 15901019879
• Email: txa00853[@]btch.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 352
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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; ….

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion		within 3, 6, and 12 months after conversion
Secondary	Graft survival rate and patient survival rate at 12 months after conversion		12 months after conversion
Secondary	The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules;		3 months after liver transplantation
Secondary	Incidence of infection (viral, bacterial and fungal) at 12 months after conversion;		12 months after conversion;
Secondary	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
Secondary	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
Secondary	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