Accelerated Immunosenescence and Chronic Kidney Disease (IRIS)

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

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Biological: Blood sample

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: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Service de néphrologie, CHU de Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telomerase Activity of T lymphocytes	The telomerase activity of T lymphocytes is assessed by a method of Polymerase chain reaction (PCR)-ELISA.	6 months
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).	6 months
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	6 months
T-cell receptor excision circle (TREC) level in PBMC.	TRECs study is based on a technique of quantitative PCR using DNA extracted from PBMC.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Jamal BAMOULID, Doctor, CHU de Besançon

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Dialysis; Renal Failure; Biological Aging
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: IRIS API/2012/28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No