Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients (EVITUPH)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Biological: Recurring blood sample; Other: dietary survey

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique H^^opitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hemodialysed patients

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite measure of uremic toxins serum levels the SI, the pCS and IAA.	blood collection	15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
dietary survey	15 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Urielle DESALBRES, Director, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2015
• Primary Completion (Actual): July 28, 2016
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimated): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2015-10; 2015-A00319-40 (Registry Identifier: ANSM); RCAPHM15_0083 (Other Identifier: APHM)