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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02818465
Other study ID # PR14037
Secondary ID
Status Completed
Phase N/A
First received June 23, 2016
Last updated April 18, 2018
Start date March 30, 2015
Est. completion date November 16, 2017

Study information

Verified date April 2018
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 16, 2017
Est. primary completion date November 16, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Vascular calcifications by Xray

Vascular calcifications by tomodentimetry

Biological:
Blood sample withdrawn


Locations

Country Name City State
France Chu de Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frammingham Score up to 12 months
See also
  Status Clinical Trial Phase
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