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Trial record 3 of 45 for:    senescent

Accelerated Immunosenescence and Chronic Kidney Disease (IRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02116270
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Renal Failure Biological: Blood sample Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Accelerated Immunosenescence and Chronic Kidney Disease
Study Start Date : September 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Control group
Patients in this group control (normal renal function) are followed in the urology department. A blood sample is performed on the day of inclusion.
Biological: Blood sample
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.

Experimental: Severe renal failure
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.
Biological: Blood sample
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.

Experimental: Peritoneal dialysis
Patients with renal failure, under peritoneal dialysis for at least 3 months. A blood sample is performed on the day of inclusion.
Biological: Blood sample
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.

Experimental: Hemodialysis
Patient with renal failure, under hemodialysis for at least 3 months. A blood sample is performed on the day of inclusion.
Biological: Blood sample
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116270


Locations
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France
Service de néphrologie, CHU de Besançon
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Jamal BAMOULID, Doctor CHU de Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02116270    
Other Study ID Numbers: IRIS API/2012/28
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Renal Failure
Dialysis
Biological Aging
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases