Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

NCT03274921 | Completed

• 2 other identifiers: RC31/16/8250University Hospital Toulouse
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Disease

Keywords

cardiovascular complications; biomarkers

Outcome Measures

Primary Outcomes (1)

• Plasma accumulation of new retention solutes

  evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry

  Day 0

Secondary Outcomes (1)

• determine their plasma concentration

  Day 0

Study Arms (2)

Cardiovascular complication

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

Diagnostic Test: Biological determination

No cardiovascular complication

patients free of any CV complications had biological determination

Diagnostic Test: Biological determination

Interventions

Biological determination DIAGNOSTIC_TEST

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

Cardiovascular complication; No cardiovascular complication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of patients consulting in University Hospital toulouse

You may qualify if:

• patient with stage 4 or 5 CKD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanislas FAGUER, MD

  University Hosptial Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 7, 2017
• Study Start: September 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)