Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 352
- 主要终点
- Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and above
- •3 months after liver transplantation;
- •Stable use of immediate-release tacrolimus for at least one month before enrollment in the study;
- •The serum levels of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] were within the normal range; ....
- •Exclusion Criteria
- •Multi-organ combined transplantation or multiple liver transplantation;
- •Multiple organ recipients or those who have previously transplanted any organs；
- •Adjuvant liver transplantation or use of bioartificial liver therapy;
- •Prior to joining the group, they had received treatment with immune checkpoint (ICIs);
- •Participation in any other clinical study within 3 months prior to enrollment;
- •Use of tacrolimus sustained release capsules before enrollment;
- •Tacrolimus trough concentration lower than 5 ng/ml at the time of screening;
- •Acute rejection occurred within one month prior to enrollment; ....
排除标准
- 未提供
研究组 & 干预措施
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)
干预措施: Tacrolimus Sustained-release Capsules (Drug)
结局指标
主要结局
Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion
时间窗: within 3, 6, and 12 months after conversion
次要结局
- 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)
- 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)
- Incidence of infection (viral, bacterial and fungal) 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)
研究者
QIAN LU
professor
Beijing Tsinghua Chang Gung Hospital