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

Primary Purpose

End-stage Chronic Kidney Failure

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Retinal photography:
dialyse
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End-stage Chronic Kidney Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

group with stage 3 kidney failure (diabetic or not)

group with stage 5 kidney failure (diabetic or not)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
May 2, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02857556
Brief Title
Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of inclusions
Study Start Date
April 17, 2014 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Chronic Kidney Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group with stage 3 kidney failure (diabetic or not)
Arm Type
Other
Arm Title
group with stage 5 kidney failure (diabetic or not)
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Type
Other
Intervention Name(s)
Retinal photography:
Intervention Type
Other
Intervention Name(s)
dialyse
Primary Outcome Measure Information:
Title
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.
Time Frame
at the beginning of the period Day 0, at 1 month and at 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

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

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