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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Terminated

Conditions

End-stage Chronic Kidney Failure

Treatments

Other: dialyse
Biological: Blood sample
Other: Retinal photography:

Study type

Interventional

Funder types

Other

Identifiers

NCT02857556
GAMBERT Fd. Transpl 2013

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

group with stage 3 kidney failure (diabetic or not)
Other group
Treatment:
Other: Retinal photography:
Biological: Blood sample
group with stage 5 kidney failure (diabetic or not)
Other group
Treatment:
Other: dialyse
Biological: Blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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