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OpenTrials
Completed

NCT Number: NCT03274921

Biomarkers 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological determination

Diagnostic Test

Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients

Primary outcomes

  1. Plasma accumulation of new retention solutes

    Time frame: Day 0

    evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry

Secondary outcomes

  1. determine their plasma concentration

    Time frame: Day 0

    determine their plasma concentration using ELISA

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: BioClaCK

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 7, 2017
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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