Uraemic Toxins in Chronic Kidney Disease Paediatric Patients: Interventional Study

NCT02634775 | Completed

• 1 other identifier: UGent_UToPaed_3
• Study Type: interventional
• Target: 60
• 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 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

Keywords

Pediatrics; Nephrology; Dialysis

Outcome Measures

Primary Outcomes (1)

• Comparison of concentrations of uraemic toxins as measured in HD patients after interventions with those as will be predicted by the kinetic model (model validation)

  up to 4 years

Secondary Outcomes (1)

• Decrease of blood concentrations of uraemic toxins in PD and HD patients by changing dialysis prescription to the optimal dialysis strategy

  up to 4 years

Study Arms (3)

CKD - no dialysis

EXPERIMENTAL

Change in treatment strategy: Start on dialysis, transplantation

Other: Change in treatment strategy

Patients on PD

EXPERIMENTAL

Change in treatment strategy: Change of PD prescription, start on HD, transplantation

Other: Change in treatment strategy

Patients on HD

EXPERIMENTAL

Change in treatment strategy: Change of HD prescription, transplantation

Other: Change in treatment strategy

Interventions

Change in treatment strategy OTHER

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

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)

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.

You may not qualify if:

• N.A.

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, 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: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 18, 2015
• Study Start: October 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

BE (1)