Biomarkers of Cardiovascular Complications in Chronic Kidney Disease (BioClaCK)

July 29, 2020 updated by: University Hospital, Toulouse

Identification of BIOmarkers for Detection and Understanding of Cardiovascular Complications in Chronic Kidney Disease

Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed associated with an increased risk of CV complications. Moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. These proteins accumulated in the plasma of patients during CKD progression and are known to be associated with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with CV complications in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients with history of CV complications in the past 4 years and 132 patients free of any CV complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

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
      • Toulouse, France, 31059
        • University Hospital Toulouse

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

Sampling Method

Non-Probability Sample

Study Population

Cohort of patients consulting in University Hospital toulouse

Description

Inclusion Criteria:

  • patient with stage 4 or 5 CKD.

Exclusion Criteria:

  • patient with stage 1, 2 or 3 CKD
  • patient with solid tumor
  • patient with malignant blood disease
  • patient with acute kidney disease in the past 3 months
  • patient with acute glomerulonephritis in the past 6 months.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiovascular complication
patients with history of CV complications in the past 4 years had biological determination
Diagnostic test: Biological determination
Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients
No cardiovascular complication
patients free of any CV complications had biological determination
Diagnostic test: Biological determination
Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma accumulation of new retention solutes
Time Frame: Day 0
evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine their plasma concentration
Time Frame: Day 0
determine their plasma concentration using ELISA
Day 0

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Stanislas FAGUER, MD, University Hosptial toulouse

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)

September 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

September 1, 2017

First Submitted That Met QC Criteria

September 4, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/8250
  • University Hospital Toulouse (Other Grant/Funding Number: 14731802)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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