A Clinical Practice Snapshot on Pediatric Kidney Transplantation

A Clinical Practice Snapshot on Pediatric Kidney Transplantation Healthcare in Europe

The aim is to create an overview of the similarities and differences in daily practice among the different centers performing pediatric kidney transplantation in Europe.

For this purpose, a Clinical Practice Snapshot will be used to provide insight in the current approaches.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Failure
• Intervention / Treatment: Other: Kidney Transplantation

Detailed Description

In order to create an overview of the current care for pediatric kidney transplant (PKT) recipients a clinical practice snapshot was developed.

All participating centers were asked to answer 6 clinical questions on their last 30 transplanted patients.

Patient characteristics, donor charactertistics, use of stents, immunosuppressive medication and renal function are compared between centers.

• Study Type: Observational
• Enrollment (Actual): 410

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500HB
    • Radboud University Medical Center

Participation Criteria

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 were transplanted in one of the participating centers and followed up for at least one month

Description

Inclusion Criteria:

• Kidney received <18 years
• at least one month of follow-up
• transplantation and follow-up in dedicated PKT center

Exclusion Criteria:

• combined transplantation

Study Plan

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	Functioning graft	at end of follow-up at least one month
Donor type	Living or deceased donor	At transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunosuppressants prescribed at discharge	Immunosuppressive medication at discharge after transplant	2 weeks
Number of infections	Viral infections after transplantations	end of follow-up, at least one month

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Kidney transplantation
• Other Study ID Numbers: PKT.Clinical.Snapshot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers from centers that contributed can request anonymized data
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No