Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure

NCT ID: NCT02857556

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-17

Study Completion Date

2017-06-30

Brief Summary

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The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.

Detailed Description

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Conditions

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End-stage Chronic Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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group with stage 3 kidney failure (diabetic or not)

Group Type OTHER

Blood sample

Intervention Type BIOLOGICAL

Retinal photography:

Intervention Type OTHER

group with stage 5 kidney failure (diabetic or not)

Group Type OTHER

Blood sample

Intervention Type BIOLOGICAL

dialyse

Intervention Type OTHER

Interventions

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Blood sample

Intervention Type BIOLOGICAL

Retinal photography:

Intervention Type OTHER

dialyse

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient who have been informed about the research
* Patients with national health insurance cover
* Patients aged between 18 and 75 years
* Patients with stage 3 kidney failure (30 ml/min \< cl creat \< 59 ml/min) diabetic or not
* Patients with stage 5 kidney failure (cl creat \< 15 ml/mn) diabetic or not and requiring dialysis.

Exclusion Criteria

* Patients under guardianship
* Pregnant or breast-feeding women
* Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site),
* Neoplastic disease,
* Systemic diseases in flare,
* Patients positive for Human Immunodeficience Virus (HIV),
* Patients on immunosuppressants
* Patients taking antioxidants (selenium, vitamin C and/or E)
* Patient on statins
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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GAMBERT Fd. Transpl 2013

Identifier Type: -

Identifier Source: org_study_id

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