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CompletedNCT03274921BioClaCKUpdated Jul 30, 2020

Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

An observational study in Chronic Renal Disease, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Renal Disease

Keywords

  • cardiovascular complications
  • biomarkers
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cohort of patients consulting in University Hospital toulouse

Inclusion criteria

  • patient with stage 4 or 5 CKD.

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testBiological determination

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

05

What researchers measure

Primary outcomes

  1. Plasma accumulation of new retention solutes

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

    Time frame: Day 0

Secondary outcomes

  1. determine their plasma concentration

    determine their plasma concentration using ELISA

    Time frame: Day 0

06

Study locations

1 site
  • University Hospital Toulouse
    Toulouse, 31059, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03274921
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Sep 1, 2017
Primary completion
Dec 31, 2019
Completion
Jun 30, 2020
Last update
Jul 30, 2020

Study contacts

Stanislas FAGUER, MD
principal investigator · University Hosptial Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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