NCT05388955

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1966

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1966

Completed
56 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
Last Updated

December 11, 2023

Status Verified

May 1, 2022

Enrollment Period

56 years

First QC Date

May 19, 2022

Last Update Submit

December 3, 2023

Conditions

Kidney Transplant Failure and RejectionPediatric Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Graft survival

    Functioning graft of death with functioning graft. Survival graph: Percentage recipients with a functioning graft over time

    Up to 50 years after transplantation

Interventions

None, transplantation recipientsOTHER

None, observational

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All pediatric kidney recipients that received their kidney \<18 years in the Netherlands

You may qualify if:

  • Pediatric kidney recipients
  • transplantation in the Netherlands
  • signed informed consent

You may not qualify if:

  • combined transplantation (pancreas-kidney of liver-kidney transplantation)
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37398686DERIVED

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Liesbeth De Wall

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 24, 2022

Study Start

January 1, 1966

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

December 11, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Not owner of the data, NOTR owns the data