Kidney Transplant Failure and RejectionNCT05388955
Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
An observational study of Kidney Transplant Failure and Rejection and Pediatric Kidney Disease, run by Radboud University Medical Center.
Trial summary
Registry study in which data of all pediatric kidney recipients in the Netherlands (registered in the Nederlandse Orgaan Transplantatie Registry) are studied to develop a risk calculator for graft loss. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Kidney Transplant Failure and Rejection, Pediatric Kidney Disease
- What is being tested?
- None, transplantation recipients
- How many people
- 1,425 participants
- Where
- No sites listed yet
- Study dates
- Jan 1966to 1 Jan 2022
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All pediatric kidney recipients that received their kidney <18 years in the Netherlands
Who may be able to join
- Pediatric kidney recipients
- transplantation in the Netherlands
- signed informed consent
Who cannot join
- combined transplantation (pancreas-kidney of liver-kidney transplantation)
- No informed consent
About this study
Official title: A Pre-transplantation Risk Assessment Tool for Graft Survival After Pediatric Kidney Transplantation Based on 1425 Dutch Transplantations
Registry study in which data of all pediatric kidney recipients in the Netherlands (registered in the Nederlandse Orgaan Transplantatie Registry) are studied to develop a risk calculator for graft loss.
Read the detailed description
The pre-transplantation parameters of all recipients are used to do a multivariable regression analysis.
The B-coefficients of this analysis will be used to develop a risk calculator that predicts graft survival after transplantation per year of transplantation.
- Being tested
- None, transplantation recipients
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, transplantation recipientsOther
None, observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Functioning graft of death with functioning graft. Survival graph: Percentage recipients with a functioning graft over time
Measured: Up to 50 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study startJan 1966
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Retrospective
- Enrolment
- 1,425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liesbeth De Wall, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388955
- Sponsor's protocol ID
- Riskcalculator.Pediatric.ntx
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not owner of the data, NOTR owns the data
Publications
Oomen L, de Jong H, Bouts AHM, Keijzer-Veen MG, Cornelissen EAM, de Wall LL, Feitz WFJ, Bootsma-Robroeks CMHHT. A pre-transplantation risk assessment tool for graft survival in Dutch pediatric kidney recipients. Clin Kidney J. 2023 Mar 23;16(7):1122-1131. doi: 10.1093/ckj/sfad057. eCollection 2023 Jul.
PubMed 37398686
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-transplantation Risk Assessment Tool for Graft Survival After Pediatric Kidney Transplantation Based on 1425 Dutch Transplantations
- ClinicalTrials.gov ID
- NCT05388955
- Acronym / sponsor ID
- Riskcalculator.Pediatric.ntx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,425 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 1966 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 24 May 2022 (actual)
- 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.
Registry study in which data of all pediatric kidney recipients in the Netherlands (registered in the Nederlandse Orgaan Transplantatie Registry) are studied to develop a risk calculator for graft loss.
Detailed description
The pre-transplantation parameters of all recipients are used to do a multivariable regression analysis.
The B-coefficients of this analysis will be used to develop a risk calculator that predicts graft survival after transplantation per year of transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pediatric kidney recipients that received their kidney <18 years in the Netherlands
Key inclusion criteria (3 listed)
- Pediatric kidney recipients
- transplantation in the Netherlands
- signed informed consent
Key exclusion criteria (2 listed)
- combined transplantation (pancreas-kidney of liver-kidney transplantation)
- No informed consent
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 |
|---|---|---|
| None, transplantation recipientsNone, observational | Other | – |
Primary outcome
Graft survival
Time frame: Up to 50 years after transplantation
Functioning graft of death with functioning graft. Survival graph: Percentage recipients with a functioning graft over time
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 11 Dec 2023.
- Derived from this study: PubMed 37398686Oomen L, de Jong H, Bouts AHM, Keijzer-Veen MG, Cornelissen EAM, de Wall LL, Feitz WFJ, Bootsma-Robroeks CMHHT. A pre-transplantation risk assessment tool for graft survival in Dutch pediatric kidney recipients. Clin Kidney J. 2023 Mar 23;16(7):1122-1131. doi: 10.1093/ckj/sfad057. eCollection 2023 Jul.
- Individual participant dataSharing planned: No. Not owner of the data, NOTR owns the data
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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.
Liesbeth De Wall principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure and Rejection and Pediatric Kidney Disease, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Graft survival (time frame: Up to 50 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388955, which also lists 1 linked publication.
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 11 Dec 2023.