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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Single arm observational registry study Drug: Tacrolimus Sustained-release Capsules | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus Sustained-release Capsules | Drug | Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Graft survival rate and patient survival rate at 12 months after conversion | 12 months after conversion | |
| The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules; | 3 months after liver transplantation |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XUAN TONG, Doctor | Contact | 15901019879 | txa00853@btch.edu.cn |
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| Incidence of infection (viral, bacterial and fungal) at 12 months after conversion; | 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 |
| 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 |