Liver Transplantation
Conditions
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.
Interventions
Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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; ….
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion | within 3, 6, and 12 months after conversion |
Secondary
| Measure | Time frame |
|---|---|
| The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules; | 3 months after liver transplantation |
| Incidence of infection (viral, bacterial and fungal) at 12 months after conversion; | 12 months after conversion; |
| Graft survival rate and patient survival rate at 12 months after conversion | 12 months after conversion |
| 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 |
| 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 |
| 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 |
Contacts
Primary ContactXUAN TONG, Doctor
Outcome results
None listed