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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02857556

Acronym

DIALYSOX

Enrollment

Registered

2016-08-05

Start date

2014-04-17

Completion date

2017-06-30

Last updated

2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Chronic Kidney Failure

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.

Interventions

BIOLOGICALBlood sample

OTHERRetinal photography:

OTHERdialyse

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026