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

End-stage Chronic Kidney Failure Clinical Trial

— DIALYSOX  

Official title:

Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure Evaluated at the Initiation of Intermittent or Peritoneal Dialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02857556
• Other study ID #: GAMBERT Fd. Transpl 2013
• Status: Terminated
• Phase: N/A
• Start date: April 17, 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End-stage Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Biological:
• Blood sample

Other:
• Retinal photography:

• dialyse

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.