Uraemic Toxins in Chronic Kidney Disease Paediatric Patients: Kinetic Analysis

NCT02620969 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-02-15

No results posted yet for this study

Summary

Children with chronic kidney disease (CKD) suffer from one of the most devastating diseases in childhood resulting in a lifelong need for health care, and a 3 times decreased life expectancy. In addition, they have important comorbidities that negatively impact on their quality of life and integration in society, jeopardizing their future even after a potential transplantation. Retention of uraemic toxins is accepted to play a major role in the pathogenesis of the comorbid conditions, but studies in children are lacking. Furthermore, there are currently no good tools to evaluate severity and monitor adequacy of treatment, resulting in suboptimal management.

The overall scientific objective of this four years UToPaed IWT-TBM project is to provide the clinician with new diagnostic and therapeutic tools for the management of children with CKD, based on the improved understanding of uraemic toxicity.

In the first part of UToPaed, the investigators will associate concentrations of a wide variety of uraemic toxins with different comorbidities in CKD children. In this second part, a kinetic analysis will be performed to unravel the distribution and transport of the different studied uraemic toxins in the body of the patient. The toxins of which concentrations are best correlated with comorbidities during the progress of CKD (UToPaed - part 1: observational study) and have representative kinetics will be selected as markers. These markers will be, together with the comorbidities, further tracked after interventions, i.e. starting on dialysis, transplantation, changes in dialysis strategy (UToPaed - part 3 - intervention study) in order to validate the different kinetic models.

From the validated kinetic models (UToPaed - part 2 and 3), an open access user-friendly prediction simulator (PAEDSIM) based on patient characteristics and marker concentrations will be developed to optimise and individualise the dialysis therapy.

By providing clinicians with more advanced and appropriate tools to improve management of all children with CKD, i.e. better assessment of the degree of renal dysfunction, better determination of the ideal time to start renal replacement therapy, and more accurate monitoring of dialysis adequacy, the investigators aim to improve neurocognitive and psychosocial functioning (short term), growth, maturation into puberty, and social integration (median term) and survival (long term).

Conditions

Interventions

OTHER

Blood and dialysate sampling

Blood and dialysate sampling

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER
  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER
  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Sunny Eloot, Prof Dr · Ghent University Hospital - Nephrology

  • Johan Vande Walle, Prof Dr · Ghent University Hospital - Paediatric Nephrology

  • Ann Raes, Prof Dr · Ghent University Hospital - Paediatric Nephrology

  • Wim Van Biesen, Prof Dr · Ghent University Hospital - Nephrology

  • Evelien Snauwaert · Ghent University Hospital - Paediatric Nephrology

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Belgium

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620969 on ClinicalTrials.gov