ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02857556
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment Phase
End-stage Chronic Kidney Failure Biological: Blood sample Other: Retinal photography: Other: dialyse Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : April 2014
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

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



Primary Outcome Measures :
  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. [ Time Frame: at the beginning of the period Day 0, at 1 month and at 3 months. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857556


Contacts
Contact: Gilbert ZANETTA 03.80.29.37.75 ext 33 gilbert.zanetta@chu-dijon.fr

Locations
France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Gilbert ZANETTA    03.80.29.37.75 ext 33    gilbert.zanetta@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02857556     History of Changes
Other Study ID Numbers: GAMBERT Fd. Transpl 2013
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic