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NCT Number: NCT02480699

Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique H^^opitaux de Marseille

Marseille, 13354, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recurring blood sample

Biological

dietary survey

Other

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 outcomes

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

    Time frame: 15 months

    blood collection

Secondary outcomes

  1. dietary survey

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: EVITUPH

Important dates

Study start
2015
Primary completion
2016
Study completion
2023
First posted
Jun 24, 2015
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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