Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Early Nephrotoxicity and/or Hypertension Due to Tacrolimus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Early and Late Pharmacokinetics of Sirolimus (SRL)
研究概览
简要总结
Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant recipients.
详细描述
Liver transplant patients receiving tacrolimus, and who experience side effects such as hypertension and renal dysfunction, will be converted to sirolimus with low-dose tacrolimus, or Tacrolimus withdrawal. This study will evaluate allograft function by serial clinical lab testing, the pharmacokinetics of sirolimus and tacrolimus, the glomerular filtration rate (GFR) and the potential side effect of sirolimus, such as marrow suppression and hyperlipidemia. Two pharmacokinetic evaluations are planned: once around the third post-transplant month and another one at about 12 months. Expected outcomes are, a better understanding of sirolimus pharmacokinetic parameters over time in pediatric/adult liver recipients and early efficacy and safety data of the sirolimus as a non-nephrotoxic alternative to tacrolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old.
- •Rejection-free post-transplant course for at least 3 months
- •Renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance)
- •Hypertension requiring anti-hypertensive mediations.
- •Informed consent.
- •Weight ≥15 kg.
排除标准
- •Rejection or infections within 3 months of enrollment.
- •Intent to continue TAC
- •Active participation in ongoing studies of immunosuppressive agents.
- •Lack of informed consent.
- •Pregnant or breast feeding
- •HIV positive
研究组 & 干预措施
Sirolimus
干预措施: Sirolimus (Drug)
结局指标
主要结局
Early and Late Pharmacokinetics of Sirolimus (SRL)
时间窗: 1 year
To evaluate early and late pharmacokinetics of Sirolimus (SRL) , and safety and efficacy of conversion from tacrolimus (TAC) to sirolimus in liver transplant recipients who have been stable for at least 3 months, and who have early nephrotoxicity and/or hypertension due to use of tacrolimus.
次要结局
- SRL Can Substitute TAC(12 months)
- SRL Prevent TAC-related Side Effects(1 year)
- PK Parameters for Tacrolimus and Sirolimus(12 months)
研究者
Rakesh Sindhi
Professor of Surgery
University of Pittsburgh