Chronic Kidney Disease Clinical Trial
— UToPaed_2Official title:
Part 2 of: 'Conceptualisation and Validation of a Paradigm Based on Uraemic Toxins for Management of Chronic Kidney Disease in Paediatric Patients (UToPaed)'
NCT number | NCT02620969 |
Other study ID # | UGent_UToPaed_2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | October 2018 |
Verified date | February 2019 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Subject Inclusion Criteria: - 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 5D and treated with haemodialysis Subject Exclusion Criteria: - N.A. |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital | Gent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | Agentschap voor Innovatie door Wetenschap en Technologie, University Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calibration of kinetic models per studied uraemic toxin | 2 years |
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