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临床试验/NCT02116270
NCT02116270已完成不适用

Accelerated Immunosenescence and Chronic Kidney Disease

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2013年9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
222
试验地点
2
主要终点
Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes)

研究概览

简要总结

The aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent T lymphocytes.

详细描述

The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation. Kidney disease is associated with a decrease in adaptive immunity as evidenced by the decrease in vaccine response and increased susceptibility to infections, similar to those observed in the elderly population.

However, data on aging of the immune system in chronic kidney disease remains incomplete. Furthermore, the determinants of immunosenescence are not also not known. It is possible that "uremic" factors help explain the phenotypic and functional changes of lymphocytes, as antigenic stimuli associated with repeated bio-compatible materials used in dialysis contact.

The purpose of this study is to describe the phenotypes of the immune system of renal and analyze the determinants of these changes.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient able to understand the reason of the study
  • Patient not opposed to the conservation of biological samples for scientific research

排除标准

  • Patient suffering from psychotic illness
  • Any history of immunosuppressive therapy (except steroids up to 5mg/day)
  • History of cancer (except skin cancer) or treated hematological malignancy
  • Infectious episode required hospitalization not older 3 months
  • Hepatitis B or C infection
  • HIV infection, active or inactive
  • For dialysis patients: renal failure on dialysis for less than 3 months and/or have benefited from two techniques for renal replacement therapy in the last 6 months

研究组 & 干预措施

Control group

Other

Patients in this group control (normal renal function) are followed in the urology department. A blood sample is performed on the day of inclusion.

干预措施: Blood sample (Biological)

Severe renal failure

Experimental

Patients in this group suffer from renal failure stage 4 and are not under dialysis. A blood sample is performed on the day of inclusion.

干预措施: Blood sample (Biological)

Peritoneal dialysis

Experimental

Patients with renal failure, under peritoneal dialysis for at least 3 months. A blood sample is performed on the day of inclusion.

干预措施: Blood sample (Biological)

Hemodialysis

Experimental

Patient with renal failure, under hemodialysis for at least 3 months. A blood sample is performed on the day of inclusion.

干预措施: Blood sample (Biological)

结局指标

主要结局

Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes)

时间窗: 6 months

The primary outcome measure is the percentage of CD 4/8+ CD 57+ CD 28- lymphocytes by flow cytometry. The technique used is a 6 colors surface labelling of T lymphocytes to study the T cell senescent population.

次要结局

  • Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes(6 months)
  • T-cell receptor excision circle (TREC) level in PBMC.(6 months)
  • Telomerase Activity of T lymphocytes(6 months)
  • Telomere length in T lymphocytes(6 months)
  • Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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