Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

Chronic Kidney Disease Clinical Trial

— EVITUPH  

Official title:

Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480699
• Other study ID #: 2015-10
• Secondary ID: 2015-A00319-40RC
• Status: Completed
• Phase: N/A
• Start date: June 20, 2015
• Est. completion date: May 25, 2023

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions. It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are implicated in cardiovascular complications associated with CKD. Several protein-bound toxins have been implicated in the increased cardiovascular risk such as indoxyl sulfate (IS), p cresol sulfate (pCS) and more recently the indole acetic acid (IAA). All clinical studies are performed with a single measurement at baseline assuming that the toxin levels are stable over time. The variability of uremic toxins level is not known. Furthermore, little is known concerning determinants of serum toxins level.

Description:

Colonic absorption play a major role in IS (indoxyl sulfate) and pCS level. IS and pCS level are significantly reduced in patient with colectomy. To validate the measurement of uremic toxins level in serum as biomarkers for cardiovascular risk, we need to know about intra-individual variability over time and the impact of diet or digestive disorders on uremic toxin serum level. We propose a prospective study evaluating the intra-individual variability in 3 uremic toxins serum levels the SI, the pCS and IAA.

The main objective is to study the kinetics of three serum uremic toxins: the indoxyl sulfate, p cresyl sulfate and indole acetic acid (and thus determine the intra-individual variability) in a population of chronic hemodialysis patients during 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 25, 2023
• Est. primary completion date: July 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major subjects of both sexes aged 18 and over

• Topics affiliates or beneficiaries of a social security scheme

• Haemodialysis patients whatever the etiology of renal failure for more than 3 months

• Patients not under antibiotic

• Agreeing to participate in the study and who signed a consent

• Patient able to understand a written questionnaire

Exclusion Criteria:

• Pregnant or lactating women

• Detainees

• Adults under legal protection or unable to consent

• Patient's refusal to sign the informed consent for participation

• Possibility of recovery of renal function (eg scleroderma)

• Patients carrying a replicating viral infection (HCV, HIV).

• Taking antibiotics in the previous month by 1 sampling

Related Conditions & MeSH terms

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

Intervention

Biological:
• Recurring blood sample

Other:
• dietary survey
A dietary survey will be performed in all patients and every 3 months (4 surveys about 1 year). This survey will be given to the patient filled for 7 consecutive days. He must record during these 7 days, all of his food intake in quality and quantity. During a dialysis session this questionnaire will be taken with the patient by a dietician to better define the food intake. This surveys requires good patient compliance as well as his involvement that his collection is well within its food intake.

Locations

Country	Name	City	State
France	Assistance Publique H^^opitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measure of uremic toxins serum levels the SI, the pCS and IAA.	blood collection	15 months
Secondary	dietary survey		15 months