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临床试验/NCT03315858
NCT03315858已完成不适用

NFAT (Nuclear Factor of Activated T-cells)-Regulated Gene Expression After Tacrolimus -the Basis for Future Tailored Immunosuppression-

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月18日最近更新:
适应症

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

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)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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