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临床试验/NCT02736227
NCT02736227已完成不适用

Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation

Northwestern University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection

研究概览

简要总结

Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize or improve kidney function for patients with chronic kidney disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care treatment to prevent transplant liver rejection in combination with other immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a combination of two different immunosuppressants and EVL to determine if patients may have stabilized and/or improved kidney function without liver rejection. This study will look at how safe it is to slowly withdraw one anti-rejection medication while continuing to take the other medicine, and whether this can be done without liver rejection occurrence.

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
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult LT candidates ≥ 18 years of age
  • Listed for or recent (within 1 month) recipient of deceased or living donor liver transplantation

排除标准

  • Combined or previous organ transplantation
  • Human immunodeficiency virus (HIV) infection
  • Inability to provide informed consent or comply with the protocol.

研究组 & 干预措施

Tacrolimus Withdrawal and Everolimus Monotherapy

Experimental

Tacrolimus will be tapered while continual use of everolimus.

干预措施: Tacrolimus Withdrawal and Everolimus Monotherapy (Drug)

结局指标

主要结局

Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection

时间窗: Six months post transplantation

flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josh Levitsky

Associate Professor in Medicine-Gastroenterology and Hepatology and Surgery-Organ Transplantation

Northwestern University

研究点 (1)

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