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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02116270
Date of registration: 09/04/2014
Prospective Registration: No
Primary sponsor: Centre Hospitalier Universitaire de Besancon
Public title: Accelerated Immunosenescence and Chronic Kidney Disease IRIS
Scientific title: Accelerated Immunosenescence and Chronic Kidney Disease
Date of first enrolment: September 2013
Target sample size: 222
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02116270
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Jamal BAMOULID, Doctor
Address: 
Telephone:
Email:
Affiliation:  CHU de Besançon
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Renal Failure
Intervention(s)
Biological: Blood sample
Primary Outcome(s)
Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes) [Time Frame: 6 months]
Secondary Outcome(s)
Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes [Time Frame: 6 months]
Telomere length in T lymphocytes [Time Frame: 6 months]
Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes [Time Frame: 6 months]
Telomerase Activity of T lymphocytes [Time Frame: 6 months]
T-cell receptor excision circle (TREC) level in PBMC. [Time Frame: 6 months]
Secondary ID(s)
IRIS API/2012/28
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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