Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

Completed

• Conditions: Chronic Renal Disease
• Interventions: Diagnostic Test: Biological determination

• Registration Number: NCT03274921
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-07
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No cardiovascular complication	Biological determination	patients free of any CV complications had biological determination
Cardiovascular complication	Biological determination	patients with history of CV complications in the past 4 years had biological determination

Primary Outcome Measures

Name	Time	Method
Plasma accumulation of new retention solutes	Day 0	evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry

Secondary Outcome Measures

Name	Time	Method
determine their plasma concentration	Day 0	determine their plasma concentration using ELISA

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France