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

NCT02857556 | Terminated

• 1 other identifier: GAMBERT Fd. Transpl 2013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Chronic Kidney Failure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

group with stage 3 kidney failure (diabetic or not)

OTHER

Biological: Blood sample; Other: Retinal photography:

group with stage 5 kidney failure (diabetic or not)

OTHER

Biological: Blood sample; Other: dialyse

Interventions

Blood sample BIOLOGICAL

group with stage 3 kidney failure (diabetic or not); group with stage 5 kidney failure (diabetic or not)

Retinal photography: OTHER

group with stage 3 kidney failure (diabetic or not)

dialyse OTHER

group with stage 5 kidney failure (diabetic or not)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

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: August 2, 2016
• First Posted: August 5, 2016
• Study Start: April 17, 2014
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

FR (1)