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Trial record 3 of 47 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

Tracking Information
First Submitted Date  ICMJE April 9, 2014
First Posted Date  ICMJE April 16, 2014
Last Update Posted Date April 5, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
  • 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.
  • 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).
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerated Immunosenescence and Chronic Kidney Disease
Official Title  ICMJE Accelerated Immunosenescence and Chronic Kidney Disease
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Renal Failure
Intervention  ICMJE Biological: Blood sample
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Blood sample
  • 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.
    Intervention: Biological: Blood sample
  • 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.
    Intervention: Biological: Blood sample
  • Experimental: Hemodialysis
    Patient with renal failure, under hemodialysis for at least 3 months. A blood sample is performed on the day of inclusion.
    Intervention: Biological: Blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2018)
222
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2014)
282
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02116270
Other Study ID Numbers  ICMJE IRIS API/2012/28
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamal BAMOULID, Doctor CHU de Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP