Chronic Kidney DiseaseUToPaed_1NCT02624466
Uraemic Toxins in Chronic Kidney Disease Paediatric Patients: Observational Study
An observational study of Chronic Kidney Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- CKD progress
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: CKD patients
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 2 to 5D, according to the K/DOQI guidelines.
Subject Exclusion Criteria:
- Partially exclusion of children and/or parents who cannot fill in the questionnaires due to language barriers. They will be excluded only from the questionnaires; the other comorbidities will be followed.
- Partially exclusion of children who cannot fill in the questionnaires due to mental retardation. They will be excluded only from the questionnaires; the other comorbidities will be followed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Part 1 of: 'Conceptualisation and Validation of a Paradigm Based on Uraemic Toxins for Management of Chronic Kidney Disease in Paediatric Patients (UToPaed)'
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.
Read more
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).
Read the detailed description
This is a prospective observational multicenter study in children (≤ 18 years) with chronic kidney disease (CKD) stage 2 to 5D with or without renal replacement therapy. In this study, 60 children with CKD stage 2 - 5 (without renal replacement therapy)(GROUP 1), 30 children with CKD stage 5D treated with peritoneal dialysis (GROUP 2) and 30 children with CKD stage 5D treated with haemodialysis (GROUP 3) will be followed for a total duration of 24 months.
The study participants are evaluated on their standard visit at the outpatient clinic every 3 months. At this visit, a blood sample for uraemic toxin concentration is withdrawn and several co-morbidities (growth, protein-energy wasting, cardiovascular disease, quality of life, psychosocial functioning, sleep, attention and executive functions) are assessed. Anthropometric parameters, dietary assessment, stool evaluation, nail evaluation, office and 24 hours ambulatory blood pressure monitoring, echocardiography and questionnaires are used to map out the several co-morbidities.
Blood analyses are performed to get the concentrations of a wide variety of uraemic toxins: i.e. small water soluble solutes, middle molecules and protein-bound solutes. All blood analyses within this project are performed in the Ghent University Hospital: i.e. urea, creatinine, calcium, and phosphorus are determined in the routine laboratory of the Ghent University Hospital using standard methods, while all other uraemic toxins are determined in the laboratory of the Nephrology Section using ELISA and (in-house developed) HPLC/UPLC techniques. For the protein-bound solutes two runs are needed to distinguish between total and free fractions of the protein-bound solutes.
The following actions are performed prior to enrolment:
- Review medical history to determine eligibility based on inclusion/exclusion criteria
- Obtain document consent from participant (>12 years) and parent/representative on study consent form
- Schedule study visits for individuals who are eligible and available for the duration of the study
- Provide potential participants with instructions needed to prepare for first study visit
Baseline visit:
- Verify inclusion/exclusion criteria.
- Obtain and record general patient information: age, sex, medical history, underlying kidney disease, medication history, current medication chart, dialysis settings and demographic information
- Assessment of dietary assessment by a skilled dietician by means of 3-day diet diary or three 24-hours recall
- Perform clinical assessment including anthropometric parameters and office blood pressure
- Perform a body composition monitoring (BCM) in children > 10 kg
- Collection of blood sample (all groups; EDTA immediately on ice; serum 15-30 minutes rest and subsequently on ice), 24 hours urine sample (group 2; 24 hours prior to visit), intradialytic urine sample (group 3) and 24 hours dialysate collection (group 2; 24 hours prior to visit) for determination of uraemic toxin concentration
Intermediate visits:
- Obtain general patient information: medication chart, changes in medical situation and dialysis settings
- Assessment of dietary intake by a skilled dietician by means of 3-day diet diary or three 24-hours recall every 3 months
- Perform clinical assessment including anthropometric parameters and office blood pressure
- Perform BCM 3-monthly in children > 10 kg with renal replacement therapy (group 2 and 3) and 1-yearly in children > 10 kg without renal replacement therapy (group 1)
- Collection of blood sample (group 1 to 3; EDTA immediately on ice; serum 15-30 minutes rest and subsequently on ice), 24 hours urine sample (group 2 and 3; 24 hours prior to visit) and 24 hours dialysate collection (group 2; 24 hours prior to visit) every 3 months for determination of uraemic toxin concentration.
- Collection of stool sample for determination of microbiota and metabolome 1-yearly (only participants of Ghent University Hospital)
- Collection of nails for determination of carbamylation process every 6 months (only participants of Ghent University Hospital)
- Perform echocardiography by a skilled paediatric cardiologist every year (visit 2, 5)
- Withdraw questionnaires from the parent and/or child assessing quality of life, attention, sleep, executive function and parental functioning every 6 months (visit 2, 4, 6, 8)
- Perform 24 hours ambulatory blood pressure measurement in children > 6 years once a year (visit 2, 5)
Final Study Visit:
- Obtain general patient information: medication chart, changes in medical situation and dialysis settings (detailed overview appendix 2)
- Assessment of dietary assessment by a skilled dietician by means of 3-day diet diary or three 24-hours recall
- Perform clinical assessment including anthropometric parameters and office blood pressure
- Perform a body composition monitoring (BCM) in children > 10 kg
- Collection of blood sample (group 1 to 3; EDTA immediately on ice; serum 15-30 minutes rest and subsequently on ice), 24 hours urine sample (group 2 and 3; 24 hours prior to visit) and 24 hours dialysate collection (group 2; 24 hours prior to visit) for determination of uraemic toxin concentration
- Perform echocardiography by a skilled paediatric cardiologist
- Perform 24 hours ambulatory blood pressure measurement in children > 6 years
The following socio-demographic questionnaires are asked to be completed:
- Assessment of quality of life (QoL)
- PedsQL for children (5-18 years)
- PedsQL for children, disease specific (8-12 years, 13-18 years)
- Parent Proxy Report by parents (2-4 years, 5-7 years, 8-12 years, 13-18 years)
- Parent Proxy Report, disease specific by parents (8-12 years, 13-18 years)
- Assessment of psychological wellbeing
- YSR for children (> 11 years)
- CBCL/TRF by parent/teachers (1,5-5 years, 6-18 years)
- CBSK for children (8-12 years), CBSA for children (13-18 years)
- Assessment of attention \& executive functions
- DBDRS by parents, teachers (6-16 years)
- BRIEF by parents/teachers (5-18 years)
- Assessment of sleep
- ESS questionnaire by parents
- CSHQ questionnaire by parents
- Assessment of family functioning
- PIP by parents
- HADS by parents
- PSI-S by parents
- PPS by parents
- CVS by parents
- Conditions
- Chronic Kidney Disease
- Being tested
- CKD progress
- Keywords
- Pediatrics, Nephrology, Dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD progressOther
CKD progress
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: CKD progress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect whether uraemic toxin concentrations are correlated with the different measured co-morbidities
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Sponsor
- Investigators
- Sunny Eloot, Prof Dr, Principal investigator, Ghent University Hospital - NephrologyJohan Vande Walle, Prof Dr, Study chair, Ghent University Hospital - Paediatric NephrologyAnn Raes, Prof Dr, Study chair, Ghent University Hospital - Paediatric NephrologyWim Van Biesen, Prof Dr, Study chair, Ghent University Hospital - NephrologyEvelien Snauwaert, Study chair, Ghent University Hospital - Paediatric Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624466
- Sponsor's protocol ID
- UGent_UToPaed_1
- Acronym
- UToPaed_1
- Status last verified
- Jan 2023
- First submitted
- 16 Nov 2015
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part 1 of: 'Conceptualisation and Validation of a Paradigm Based on Uraemic Toxins for Management of Chronic Kidney Disease in Paediatric Patients (UToPaed)'
- ClinicalTrials.gov ID
- NCT02624466
- Acronym / sponsor ID
- UToPaed_1 / UGent_UToPaed_1
- Conditions
- Chronic Kidney Disease
- Keywords
- Pediatrics, Nephrology, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Oct 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a prospective observational multicenter study in children (≤ 18 years) with chronic kidney disease (CKD) stage 2 to 5D with or without renal replacement therapy. In this study, 60 children with CKD stage 2 - 5 (without renal replacement therapy)(GROUP 1), 30 children with CKD stage 5D treated with peritoneal dialysis (GROUP 2) and 30 children with CKD stage 5D treated with haemodialysis (GROUP 3) will be followed for a total duration of 24 months.
The study participants are evaluated on their standard visit at the outpatient clinic every 3 months. At this visit, a blood sample for uraemic toxin concentration is withdrawn and several co-morbidities (growth, protein-energy wasting, cardiovascular disease, quality of life, psychosocial functioning, sleep, attention and executive functions) are assessed. Anthropometric parameters, dietary assessment, stool evaluation, nail evaluation, office and 24 hours ambulatory blood pressure monitoring, echocardiography and questionnaires are used to map out the several co-morbidities.
Blood analyses are performed to get the concentrations of a wide variety of uraemic toxins: i.e. small water soluble solutes, middle molecules and protein-bound solutes. All blood analyses within this project are performed in the Ghent University Hospital: i.e. urea, creatinine, calcium, and phosphorus are determined in the routine laboratory of the Ghent University Hospital using standard methods, while all other uraemic toxins are determined in the laboratory of the Nephrology Section using ELISA and (in-house developed) HPLC/UPLC techniques. For the protein-bound solutes two runs are needed to distinguish between total and free fractions of the protein-bound solutes.
The following actions are performed prior to enrolment:
- Review medical history to determine eligibility based on inclusion/exclusion criteria
- Obtain document consent from participant (>12 years) and parent/representative on study consent form
- Schedule study visits for individuals who are eligible and available for the duration of the study
- Provide potential participants with instructions needed to prepare for first study visit
Baseline visit:
- Verify inclusion/exclusion criteria.
- Obtain and record general patient information: age, sex, medical history, underlying kidney disease, medication history, current medication chart, dialysis settings and demographic information
- Assessment of dietary assessment by a skilled dietician by means of 3-day diet diary or three 24-hours recall
- Perform clinical assessment including anthropometric parameters and office blood pressure
- Perform a body composition monitoring (BCM) in children > 10 kg
- Collection of blood sample (all groups; EDTA immediately on ice; serum 15-30 minutes rest and subsequently on ice), 24 hours urine sample (group 2; 24 hours prior to visit), intradialytic urine sample (group 3) and 24 hours dialysate collection (group 2; 24 hours prior to visit) for determination of uraemic toxin concentration
Intermediate visits:
- Obtain general patient information: medication chart, changes in medical situation and dialysis settings
- Assessment of dietary intake by a skilled dietician by means of 3-day diet diary or three 24-hours recall every 3 months
- Perform clinical assessment including anthropometric parameters and office blood pressure
- Perform BCM 3-monthly in children > 10 kg with renal replacement therapy (group 2 and 3) and 1-yearly in children > 10 kg without renal replacement therapy (group 1)
- Collection of blood sample (group 1 to 3; EDTA immediately on ice; serum 15-30 minutes rest and subsequently on ice), 24 hours urine sample (group 2 and 3; 24 hours prior to visit) and 24 hours dialysate collection (group 2; 24 hours prior to visit) every 3 months for determination of uraemic toxin concentration.
- Collection of stool sample for determination of microbiota and metabolome 1-yearly (only participants of Ghent University Hospital)
- Collection of nails for determination of carbamylation process every 6 months (only participants of Ghent University Hospital)
- Perform echocardiography by a skilled paediatric cardiologist every year (visit 2, 5)
- Withdraw questionnaires from the parent and/or child assessing quality of life, attention, sleep, executive function and parental functioning every 6 months (visit 2, 4, 6, 8)
- Perform 24 hours ambulatory blood pressure measurement in children > 6 years once a year (visit 2, 5)
Final Study Visit:
- Obtain general patient information: medication chart, changes in medical situation and dialysis settings (detailed overview appendix 2)
- Assessment of dietary assessment by a skilled dietician by means of 3-day diet diary or three 24-hours recall
- Perform clinical assessment including anthropometric parameters and office blood pressure
- Perform a body composition monitoring (BCM) in children > 10 kg
- Collection of blood sample (group 1 to 3; EDTA immediately on ice; serum 15-30 minutes rest and subsequently on ice), 24 hours urine sample (group 2 and 3; 24 hours prior to visit) and 24 hours dialysate collection (group 2; 24 hours prior to visit) for determination of uraemic toxin concentration
- Perform echocardiography by a skilled paediatric cardiologist
- Perform 24 hours ambulatory blood pressure measurement in children > 6 years
The following socio-demographic questionnaires are asked to be completed:
- Assessment of quality of life (QoL)
- PedsQL for children (5-18 years)
- PedsQL for children, disease specific (8-12 years, 13-18 years)
- Parent Proxy Report by parents (2-4 years, 5-7 years, 8-12 years, 13-18 years)
- Parent Proxy Report, disease specific by parents (8-12 years, 13-18 years)
- Assessment of psychological wellbeing
- YSR for children (> 11 years)
- CBCL/TRF by parent/teachers (1,5-5 years, 6-18 years)
- CBSK for children (8-12 years), CBSA for children (13-18 years)
- Assessment of attention \& executive functions
- DBDRS by parents, teachers (6-16 years)
- BRIEF by parents/teachers (5-18 years)
- Assessment of sleep
- ESS questionnaire by parents
- CSHQ questionnaire by parents
- Assessment of family functioning
- PIP by parents
- HADS by parents
- PSI-S by parents
- PPS by parents
- CVS by parents
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD - no dialysis | – | Other: CKD progressFollow-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. |
| Patients on PD | – | Other: CKD progressFollow-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. |
| Patients on HD | – | Other: CKD progressFollow-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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- CKD patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD progressCKD progress | Other | CKD - no dialysis, Patients on HD, Patients on PD |
Primary outcome
Detect whether uraemic toxin concentrations are correlated with the different measured co-morbidities
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunny Eloot, Prof Dr principal investigator
Ghent University Hospital - Nephrology
Johan Vande Walle, Prof Dr study chair
Ghent University Hospital - Paediatric Nephrology
Ann Raes, Prof Dr study chair
Ghent University Hospital - Paediatric Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect whether uraemic toxin concentrations are correlated with the different measured co-morbidities (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.