Uraemic Toxins in Chronic Kidney Disease Paediatric Patients: Observational Study

NCT02624466 | Completed

• 1 other identifier: UGent_UToPaed_1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 this first part of UToPaed, 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). The toxins of which concentrations are best correlated with comorbidities during the progress of CKD and eventually have representative kinetics (UToPaed - part 2: Kinetic analysis) 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). 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

Keywords

Pediatrics; Nephrology; Dialysis

Outcome Measures

Primary Outcomes (1)

• Detect whether uraemic toxin concentrations are correlated with the different measured co-morbidities

  2 years

Study Arms (3)

CKD - no dialysis

Follow-up of CKD progress by frequent assessment of: concentration of uraemic toxins in blood, anthropometry, cardio-vascular parameters, body composition monitoring, dietary assessment, psycho-social questionnaires, sleep disorders, stool, nails.

Other: CKD progress

Patients on PD

Follow-up of CKD progress by frequent assessment of: concentration of uraemic toxins in blood, urine and PD fluid, anthropometry, cardio-vascular parameters, body composition monitoring, dietary assessment, psycho-social questionnaires, sleep disorders, stool, nails.

Other: CKD progress

Patients on HD

Follow-up of CKD progress by frequent assessment of: concentration of uraemic toxins in blood, urine and spent dialysate, anthropometry, cardio-vascular parameters, body composition monitoring, dietary assessment, psycho-social questionnaires, sleep disorders, stool, nails.

Other: CKD progress

Interventions

CKD progress OTHER

CKD progress

CKD - no dialysis; Patients on HD; Patients on PD

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

CKD patients

You may qualify if:

• Provide signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, aged ≤ 18 years
• Diagnosed with chronic kidney disease stage 2 to 5D, according to the K/DOQI guidelines.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (1)

Ghent University Hospital - Nephrology

Ghent, 9000, Belgium

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

• Sunny Eloot, Prof Dr

  Ghent University Hospital - Nephrology

  PRINCIPAL INVESTIGATOR

• Johan Vande Walle, Prof Dr

  Ghent University Hospital - Paediatric Nephrology

  STUDY CHAIR

• Ann Raes, Prof Dr

  Ghent University Hospital - Paediatric Nephrology

  STUDY CHAIR

• Wim Van Biesen, Prof Dr

  Ghent University Hospital - Nephrology

  STUDY CHAIR

• Evelien Snauwaert

  Ghent University Hospital - Paediatric Nephrology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: December 8, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

BE (1)