Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

NCT02480699 | Completed

• 3 other identifiers: 2015-102015-A00319-40RCAPHM15_0083
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

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

  blood collection

  15 months

Secondary Outcomes (1)

• dietary survey

  15 months

Study Arms (1)

Hemodialysed patients

EXPERIMENTAL

Biological: Recurring blood sample; Other: dietary survey

Interventions

Recurring blood sample BIOLOGICAL

Hemodialysed patients

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.

Hemodialysed patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique H^^opitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Urielle DESALBRES, Director

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: June 20, 2015
• Primary Completion: July 28, 2016
• Study Completion: May 25, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

FR (1)