Biomarkers of Cardiovascular Complications in Chronic Kidney Disease (BioClaCK)

Toulouse University Hospital

Status: Completed

Conditions: Chronic Renal Disease

Treatments: Diagnostic Test: Biological determination

Study type: Observational

Funder types: Other

Identifiers

NCT03274921

RC31/16/8250

University Hospital Toulouse

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

130 participants in 2 patient groups

Cardiovascular complication

Description:

patients with history of CV complications in the past 4 years had biological determination

Treatment:

Diagnostic Test: Biological determination

No cardiovascular complication

Description:

patients free of any CV complications had biological determination

Treatment:

Diagnostic Test: Biological determination