Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

Chronic Renal Disease Clinical Trial

— BioClaCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274921
• Other study ID #: RC31/16/8250
• Secondary ID: University Hospi
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Biological determination
Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma accumulation of new retention solutes	evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry	Day 0
Secondary	determine their plasma concentration	determine their plasma concentration using ELISA	Day 0