NFAT (Nuclear Factor of Activated T-cells)-Regulated Gene Expression After Tacrolimus -the Basis for Future Tailored Immunosuppression-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- correlation of NFAT-RGE and TAC peak levels
研究概览
简要总结
Aim of the study is measurement of NFAT-RGE (IL-2 (interleukin-2), IFN-γ (interferon-gamma), GM-CSF (granulocyte monocyte colony stimulating factor)) after tacrolimus (TAC) in de-novo immunosuppressed patients after liver transplantation (LT), to test the hypothesis that in de-novo TAC patients receiving mycophenolate mofetil (MMF) and steroids after LT there is an inverse correlation of NFAT-RGE and TAC peak levels at 1.5 hours after TAC intake.
详细描述
The trial will be conducted as a prospective, longitudinal study. The study is a single-centre study performed at the Medical University of Graz, Department of Surgery, Division of Transplant Surgery and the Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz.
All the patients on the LT wailting list at the Division of Transplant Surgery, Medical University of Graz are screened according to both inclusion and exclusion criteria. The study period is 1 year. One NFAT-RGE baseline measurement is performed directly before LT; NFAT-RGE-measurements after LT are performed at clearly defined timepoints.
Study population. As a pilot trial this study comprises of 15 patients who will undergo LT
Objectives:
- To test the hypothesis that in de-novo TAC patients receiving mycophenolate mofetil (MMF) and steroids after LT there is an inverse correlation of NFAT-RGE and TAC peak levels at 1.5 hours after TAC intake
- To correlate both NFAT-RGE and TAC (trough and peak) levels with rejection episodes and TAC side effects
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age
- •Liver transplantation
- •Informed consent
排除标准
- •Patients < 18 of years
- •Patients taking actively part in a different interventional trial
结局指标
主要结局
correlation of NFAT-RGE and TAC peak levels
时间窗: 1 year
Calculation: cpeak/c0x100
次要结局
- correlation of both NFAT-RGE and TAC (trough and peak) levels with rejection episodes and TAC side effects(1 year)
