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Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03274921
Acronym
BioClaCK
Enrollment
130
Registered
2017-09-07
Start date
2017-09-01
Completion date
2020-06-30
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Disease

Keywords

cardiovascular complications, biomarkers

Brief summary

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.

Interventions

DIAGNOSTIC_TESTBiological determination

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma accumulation of new retention solutesDay 0evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry

Secondary

MeasureTime frameDescription
determine their plasma concentrationDay 0determine their plasma concentration using ELISA

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026