Uraemic Toxins in Chronic Kidney Disease Paediatric Patients: Interventional 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 UToPaed (part 1), the investigators will associate concentrations of a wide variety of uraemic toxins with different comorbidities in CKD children, i.e. growth, protein-energy wasting, quality of life, cardiovascular risk factors, circadian rhythm, sleep quality, and psychosocial and neurocognitive functioning (i.e. cross-sectional and longitudinal). Those toxins of which concentrations are best correlated with comorbidities during the progress of CKD and those having representative kinetics (UToPaed - part 2: Kinetic analysis) will be selected as markers. During this third part of UToPaed, these markers will be, together with the comorbidities, further tracked after interventions, i.e. starting on dialysis, transplantation, changes in dialysis strategy.

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

• Chronic Kidney Disease

Interventions

OTHER

Change in treatment strategy

Start on dialysis, transplantation, change of PD prescription, change of HD prescription

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Belgium

Study Locations