NCT02818465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
Last Updated

January 21, 2026

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

June 23, 2016

Last Update Submit

January 19, 2026

Conditions

Hemodialyzed Patients

Outcome Measures

Primary Outcomes (1)

  • Frammingham Score

    up to 12 months

Study Arms (1)

Patients

EXPERIMENTAL
Other: Vascular calcifications by XrayOther: Vascular calcifications by tomodentimetryBiological: Blood sample withdrawn

Interventions

Vascular calcifications by XrayOTHER
Patients
Vascular calcifications by tomodentimetryOTHER
Patients
Blood sample withdrawnBIOLOGICAL
Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

Related Publications (1)

  • Belmokhtar K, Ortillon J, Jaisson S, Massy ZA, Boulagnon Rombi C, Doue M, Maurice P, Fritz G, Gillery P, Schmidt AM, Rieu P, Toure F. Receptor for advanced glycation end products: a key molecule in the genesis of chronic kidney disease vascular calcification and a potential modulator of sodium phosphate co-transporter PIT-1 expression. Nephrol Dial Transplant. 2019 Dec 1;34(12):2018-2030. doi: 10.1093/ndt/gfz012.

    PMID: 30778553BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 29, 2016

Study Start

March 30, 2015

Primary Completion

November 16, 2017

Study Completion

November 16, 2017

Last Updated

January 21, 2026

Record last verified: 2018-04

Locations

FR(1)