Chronic Kidney DiseaseUToPaed_3NCT02634775
Uraemic Toxins in Chronic Kidney Disease Paediatric Patients: Interventional Study
A study testing Change in treatment strategy in people with 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?
- Change in treatment strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to 31 Dec 2018
- Phase
- Interventional
- 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
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:
- N.A.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Part 3 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 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).
Read the detailed description
This is an interventional multicenter study in children (≤ 18 years) with chronic kidney disease (CKD) stage 2 to 5D with or without renal replacement therapy. They will be followed for a total duration of 24 months.
Concentrations of the uraemic toxin markers and the different comorbidities will be followed after an intervention. Some interventions will just happen in the treatment of the CKD child: e.g. transplantation, start on dialysis, needed switch from PD to HD.
In the patients on PD, different approaches will be followed: more frequent exchanges overnight, PET-directed dialysis regimes, adapted PD, using a mix of short, small volume dwells, with longer, high volume dwells. These different strategies have so far only been tested using the classic adequacy parameters urea and creatinine. The intervention is that the children, as included in the longitudinal study, will be studied while on at least two different PD strategies, serving as their own control, whereby the strategy will be linked with the concentration of the uraemic toxin markers and comorbidities.
In the patients on HD, different dialysis strategies will be studied: conventional haemodialysis 3x/week, daily haemodialysis, haemodiafiltration 3x/week, nocturnal 8h dialysis 3x/week, and the optimal dialysis regime as derived from the kinetic analysis (UToPaed_2). The intervention is that the children, as included in the longitudinal study, will be studied with at least 2 of the strategies, and that differences in plasma concentrations and removal rate of the uraemic toxin markers will be measured. The measured predialysis concentrations, time averaged concentrations (TACs), and total solute removal with the different strategies will be compared to the results of the kinetic simulations in order to validate the calibrated kinetic models of the uraemic toxin markers.
Based on the results, guidance on the most optimal dialysis strategy for each child will be developed, and the child will consequently be treated on that modality during 1 year, to allow evaluation of the longer term impact on quality of life, catch up growth, study results and emergence of new comorbidities.
The therapeutic tool comprises an open access user-friendly prediction simulator, based on the kinetics of the new markers (PAEDSIM) to simulate different dialysis strategies. With different patient characteristics and uraemic toxin concentrations as input for the simulation model, the program will derive the optimal dialysis strategy for the individual patient striving for low predialysis concentrations and TACs.
The clinical use of these findings will be promoted by the organisation of a 'CKD Academy' with workshops about the prediction simulator (PAEDSIM) and the related laboratory techniques (see utilisation strategies).
- Conditions
- Chronic Kidney Disease
- Being tested
- Change in treatment strategy
- 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.
Change in treatment strategyOther
Start on dialysis, transplantation, change of PD prescription, change of HD prescription
| Study group | Role | What they receive |
|---|---|---|
| CKD - no dialysis | Experimental | Change in treatment strategy: Start on dialysis, transplantation Receives: Other: Change in treatment strategy |
| Patients on PD | Experimental | Change in treatment strategy: Change of PD prescription, start on HD, transplantation Receives: Other: Change in treatment strategy |
| Patients on HD | Experimental | Change in treatment strategy: Change of HD prescription, transplantation Receives: Other: Change in treatment strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02634775
- Sponsor's protocol ID
- UGent_UToPaed_3
- Acronym
- UToPaed_3
- Status last verified
- Aug 2021
- First submitted
- 1 Dec 2015
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part 3 of: 'Conceptualisation and Validation of a Paradigm Based on Uraemic Toxins for Management of Chronic Kidney Disease in Paediatric Patients (UToPaed)'
- ClinicalTrials.gov ID
- NCT02634775
- Acronym / sponsor ID
- UToPaed_3 / UGent_UToPaed_3
- Conditions
- Chronic Kidney Disease
- Keywords
- Pediatrics, Nephrology, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 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
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 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 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).
Detailed description
This is an interventional multicenter study in children (≤ 18 years) with chronic kidney disease (CKD) stage 2 to 5D with or without renal replacement therapy. They will be followed for a total duration of 24 months.
Concentrations of the uraemic toxin markers and the different comorbidities will be followed after an intervention. Some interventions will just happen in the treatment of the CKD child: e.g. transplantation, start on dialysis, needed switch from PD to HD.
In the patients on PD, different approaches will be followed: more frequent exchanges overnight, PET-directed dialysis regimes, adapted PD, using a mix of short, small volume dwells, with longer, high volume dwells. These different strategies have so far only been tested using the classic adequacy parameters urea and creatinine. The intervention is that the children, as included in the longitudinal study, will be studied while on at least two different PD strategies, serving as their own control, whereby the strategy will be linked with the concentration of the uraemic toxin markers and comorbidities.
In the patients on HD, different dialysis strategies will be studied: conventional haemodialysis 3x/week, daily haemodialysis, haemodiafiltration 3x/week, nocturnal 8h dialysis 3x/week, and the optimal dialysis regime as derived from the kinetic analysis (UToPaed_2). The intervention is that the children, as included in the longitudinal study, will be studied with at least 2 of the strategies, and that differences in plasma concentrations and removal rate of the uraemic toxin markers will be measured. The measured predialysis concentrations, time averaged concentrations (TACs), and total solute removal with the different strategies will be compared to the results of the kinetic simulations in order to validate the calibrated kinetic models of the uraemic toxin markers.
Based on the results, guidance on the most optimal dialysis strategy for each child will be developed, and the child will consequently be treated on that modality during 1 year, to allow evaluation of the longer term impact on quality of life, catch up growth, study results and emergence of new comorbidities.
The therapeutic tool comprises an open access user-friendly prediction simulator, based on the kinetics of the new markers (PAEDSIM) to simulate different dialysis strategies. With different patient characteristics and uraemic toxin concentrations as input for the simulation model, the program will derive the optimal dialysis strategy for the individual patient striving for low predialysis concentrations and TACs.
The clinical use of these findings will be promoted by the organisation of a 'CKD Academy' with workshops about the prediction simulator (PAEDSIM) and the related laboratory techniques (see utilisation strategies).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD - no dialysis | Experimental | Other: Change in treatment strategyChange in treatment strategy: Start on dialysis, transplantation |
| Patients on PD | Experimental | Other: Change in treatment strategyChange in treatment strategy: Change of PD prescription, start on HD, transplantation |
| Patients on HD | Experimental | Other: Change in treatment strategyChange in treatment strategy: Change of HD prescription, transplantation |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Change in treatment strategyStart on dialysis, transplantation, change of PD prescription, change of HD prescription | Other | CKD - no dialysis, Patients on HD, Patients on PD |
Primary outcome
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)
Time frame: up to 4 years
1 secondary outcome
Decrease of blood concentrations of uraemic toxins in PD and HD patients by changing dialysis prescription to the optimal dialysis strategy
Time frame: up to 4 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 16 Aug 2021.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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?
A study testing Change in treatment strategy in people with 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 16 Aug 2021. 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?
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) (time frame: up to 4 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 16 Aug 2021.