Role of the Interaction Between Advanced Glycation End Products and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients (RAGE-VASCU)

April 18, 2018 updated by: CHU de Reims

Role of the Interaction Between AGEs and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients

Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest, advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze the role of RAGE in the calcification process of hemodialyzed patients, in a correlative and prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while accumulation of AGEs will be measured in the serum and in the skin (non invasive). Additionally factors influencing RAGE activation such as genetic polymorphism and level of soluble forms of RAGE will be measured and analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Renal impairment
  • Hemodialysis for more than 3 months
  • Have agreed to participate in research
  • Affiliated to a social security scheme
  • major

Exclusion Criteria:

  • Diabetes , for diabetes induces accelerated formation of advanced glycation end products , which could then be a confounding factor in our study.
  • Protected by law .
  • minors
  • pregnant women
  • Matt or pigmented skin because the skin hyperpigmentation interfere with reading the skin fluorescence giving falsely elevated values .
  • Having an aneurysm of the abdominal aorta known
  • Suffering from a progressive neoplastic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Other: Vascular calcifications by Xray
Other: Vascular calcifications by tomodentimetry
Biological: Blood sample withdrawn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frammingham Score
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2015

Primary Completion (Actual)

November 16, 2017

Study Completion (Actual)

November 16, 2017

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR14037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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