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临床试验/NCT01771705
NCT01771705已完成不适用

NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
•Number of adjustments made to tacrolimus regimen at 6 months; •Lack of correlation between NFAT-dependent cytokine expression and tacrolimus trough levels

研究概览

简要总结

The purpose of this study is to compare two different ways of monitoring the immune system to determine how to manage the doses of anti-rejection medications.

详细描述

This is a single center randomized controlled trial investigating the efficacy and safety of adjusting calcineurin inhibitor (CNI) dosing based on Nuclear Factor of Activating T Cells (NFAT)-dependent cytokine gene expression as compared to standard of care adjustments based on trough level. Before any study-related evaluations are performed, the patient must give written informed consent. Once consent is obtained, a patient's eligibility to participate in the study will be assessed within 4 weeks of their 6 month management biopsy. Approximately 40 patients who meet inclusion criteria will be randomized at University of California, San Francisco (UCSF). Eligible patients include any patient maintained on triple therapy with tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior rejection episodes and who has undergone a 6 month management kidney biopsy that shows no evidence of acute cellular rejection or antibody mediated rejection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible patients include any patient maintained on triple therapy with tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior rejection episodes and who has undergone a 6 month management kidney biopsy that shows no evidence of acute cellular rejection or antibody mediated rejection.

排除标准

  • Any patient not maintained on triple therapy with tacrolimus, mycophenolate mofetil and steroids and/or who had evidence of rejection on 6- month management biopsy.

结局指标

主要结局

•Number of adjustments made to tacrolimus regimen at 6 months; •Lack of correlation between NFAT-dependent cytokine expression and tacrolimus trough levels

时间窗: 6 Months

次要结局

  • 1 year (18 months post-transplant) biopsy proven acute rejections episodes(12 Months)
  • 1 year (18 months post-transplant) cumulative infectious complications(12 Months)
  • 1 year (18 months post-transplant) allograft survival(12 Months)
  • 1 year (18 months post-transplant) patient survival(12 Months)
  • 1 year (18 months post-transplant) GFR(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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