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Accelerated Immunosenescence and Chronic Kidney Disease (IRIS)

Primary Purpose

Renal Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Failure focused on measuring Renal Failure, Dialysis, Biological Aging

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de néphrologie, CHU de Besançon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

Control group

Severe renal failure

Peritoneal dialysis

Hemodialysis

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

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

Telomerase Activity of T lymphocytes
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
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
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.
TRECs study is based on a technique of quantitative PCR using DNA extracted from PBMC.
Telomere length in T lymphocytes
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.

Full Information

First Posted
April 9, 2014
Last Updated
April 4, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02116270
Brief Title
Accelerated Immunosenescence and Chronic Kidney Disease
Acronym
IRIS
Official Title
Accelerated Immunosenescence and Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Renal Failure, Dialysis, Biological Aging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Patients in this group control (normal renal function) are followed in the urology department. A blood sample is performed on the day of inclusion.
Arm Title
Severe renal failure
Arm Type
Experimental
Arm Description
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.
Arm Title
Peritoneal dialysis
Arm Type
Experimental
Arm Description
Patients with renal failure, under peritoneal dialysis for at least 3 months. A blood sample is performed on the day of inclusion.
Arm Title
Hemodialysis
Arm Type
Experimental
Arm Description
Patient with renal failure, under hemodialysis for at least 3 months. A blood sample is performed on the day of inclusion.
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.
Primary Outcome Measure Information:
Title
Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Telomerase Activity of T lymphocytes
Description
The telomerase activity of T lymphocytes is assessed by a method of Polymerase chain reaction (PCR)-ELISA.
Time Frame
6 months
Title
Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes
Description
This level is obtained by flow cytometry after permeabilization and labelling of Peripheral Blood Mononuclear Cells (PBMC).
Time Frame
6 months
Title
Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes
Description
RTE T cells will be defined by flow cytometry, according to co-expression of CD 4, CD 8,CD 31 and CD 45RA
Time Frame
6 months
Title
T-cell receptor excision circle (TREC) level in PBMC.
Description
TRECs study is based on a technique of quantitative PCR using DNA extracted from PBMC.
Time Frame
6 months
Title
Telomere length in T lymphocytes
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamal BAMOULID, Doctor
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de néphrologie, CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Accelerated Immunosenescence and Chronic Kidney Disease

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