Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
December 3, 2023 updated by: Radboud University Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
1425
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All pediatric kidney recipients that received their kidney <18 years in the Netherlands
Description
Inclusion Criteria:
Pediatric kidney recipients
- transplantation in the Netherlands
- signed informed consent
Exclusion Criteria:
- combined transplantation (pancreas-kidney of liver-kidney transplantation)
- No informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Up to 50 years after transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Liesbeth De Wall, Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 1966
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
May 19, 2022
First Submitted That Met QC Criteria
May 19, 2022
First Posted (Actual)
May 24, 2022
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 3, 2023
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riskcalculator.Pediatric.ntx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not owner of the data, NOTR owns the data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.