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Completed

NCT Number: NCT02116270

Accelerated Immunosenescence and Chronic Kidney Disease

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

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de néphrologie, CHU de Besançon

Besançon, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Blood sample

Biological

3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Telomerase Activity of T lymphocytes

    Time frame: 6 months

    The telomerase activity of T lymphocytes is assessed by a method of Polymerase chain reaction (PCR)-ELISA.

  2. Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes

    Time frame: 6 months

    This level is obtained by flow cytometry after permeabilization and labelling of Peripheral Blood Mononuclear Cells (PBMC).

  3. Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes

    Time frame: 6 months

    RTE T cells will be defined by flow cytometry, according to co-expression of CD 4, CD 8,CD 31 and CD 45RA

  4. T-cell receptor excision circle (TREC) level in PBMC.

    Time frame: 6 months

    TRECs study is based on a technique of quantitative PCR using DNA extracted from PBMC.

  5. Telomere length in T lymphocytes

    Time frame: 6 months

    Study of telomere length is performed after extraction of DNA from isolated T cells. The length is determined by a quantitative PCR technique relative to a reference gene.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: IRIS

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Apr 16, 2014
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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