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

Not Applicable

Terminated

• Conditions: End-stage Chronic Kidney Failure
• Interventions: Biological: Blood sample; Other: dialyse

• Registration Number: NCT02857556
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-04-17
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group with stage 3 kidney failure (diabetic or not)	Blood sample	-
group with stage 5 kidney failure (diabetic or not)	Blood sample	-
group with stage 5 kidney failure (diabetic or not)	dialyse	-

Primary Outcome Measures

Name	Time	Method
Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot.	at the beginning of the period Day 0, at 1 month and at 3 months.

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France