Accelerated Immunosenescence and Chronic Kidney Disease

Renal Failure Clinical Trial

— IRIS  

Official title:

Accelerated Immunosenescence and Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116270
• Other study ID #: IRIS API/2012/28
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: April 4, 2018
• Start date: September 2013
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: January 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Biological:
• Blood sample
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.

Locations

Country	Name	City	State
France	Service de néphrologie, CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Telomerase Activity of T lymphocytes	The telomerase activity of T lymphocytes is assessed by a method of Polymerase chain reaction (PCR)-ELISA.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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