Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

NCT ID: NCT03274921

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Chronic Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiovascular complication

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

Biological determination

Intervention Type DIAGNOSTIC_TEST

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

No cardiovascular complication

patients free of any CV complications had biological determination

Biological determination

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Biological determination

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stanislas FAGUER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hosptial Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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University Hospital Toulouse

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC31/16/8250

Identifier Type: -

Identifier Source: org_study_id

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