Back to resultsRole 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)
Primary Purpose
Hemodialyzed Patients
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vascular calcifications by Xray
Vascular calcifications by tomodentimetry
Blood sample withdrawn
Sponsored by
About this trial
This is an interventional basic science trial for Hemodialyzed Patients
Eligibility Criteria
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
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
Frammingham Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02818465
Brief Title
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
Acronym
RAGE-VASCU
Official Title
Role of the Interaction Between AGEs and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2015 (Actual)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialyzed Patients
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Vascular calcifications by Xray
Intervention Type
Other
Intervention Name(s)
Vascular calcifications by tomodentimetry
Intervention Type
Biological
Intervention Name(s)
Blood sample withdrawn
Primary Outcome Measure Information:
Title
Frammingham Score
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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