NCT02116270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

April 9, 2014

Last Update Submit

April 4, 2018

Conditions

Renal Failure

Keywords

Renal FailureDialysisBiological Aging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Telomerase Activity of T lymphocytes

    6 months

  • Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes

    6 months

  • Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes

    6 months

  • T-cell receptor excision circle (TREC) level in PBMC.

    6 months

  • Telomere length in T lymphocytes

    6 months

Study Arms (4)

Control group

OTHER

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

Severe renal failure

EXPERIMENTAL

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

Peritoneal dialysis

EXPERIMENTAL

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

Hemodialysis

EXPERIMENTAL

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

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.

Control groupHemodialysisPeritoneal dialysisSevere renal failure

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient able to understand the reason of the study
  • Patient not opposed to the conservation of biological samples for scientific research

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de néphrologie, CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jamal BAMOULID, Doctor

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 16, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2016

Study Completion

January 1, 2017

Last Updated

April 5, 2018

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)