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

Primary Purpose

Chronic Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Recurring blood sample

dietary survey

About this trial

This is an interventional diagnostic trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assistance Publique H^^opitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemodialysed patients

Arm Description

Outcomes

Primary Outcome Measures

Composite measure of uremic toxins serum levels the SI, the pCS and IAA.

blood collection

Secondary Outcome Measures

dietary survey

Full Information

NCT ID

NCT02480699

First Posted

June 22, 2015

Last Updated

May 25, 2023

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT02480699

Brief Title

Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

Acronym

EVITUPH

Official Title

Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

June 20, 2015 (Actual)

Primary Completion Date

July 28, 2016 (Actual)

Study Completion Date

May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hemodialysed patients

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Recurring blood sample

Intervention Type

Other

Intervention Name(s)

dietary survey

Intervention Description

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.

Primary Outcome Measure Information:

Title

Composite measure of uremic toxins serum levels the SI, the pCS and IAA.

Description

blood collection

Time Frame

15 months

Secondary Outcome Measure Information:

Title

dietary survey

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Urielle DESALBRES, Director

Organizational Affiliation

Assistance Publique Hôpitaux de Marseille

Official's Role

Study Director

Facility Information:

Facility Name

Assistance Publique H^^opitaux de Marseille

City

Marseille

ZIP/Postal Code

13354

Country

France

12. IPD Sharing Statement

Learn more about this trial

Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

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