A Clinical Practice Snapshot on Pediatric Kidney Transpla... | NCT05619679

Studies
A Clinical Practice Snapshot on Pediatric Kidney Transplantation

NCT05619679

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Dec 5, 2023Actual

Enrollment

410Actual

Phase

Not provided

Conditions

Kidney Transplant Failure

Interventions

Kidney Transplantation

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2022Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Nov 9, 2022

First Submission Date that Met QC Criteria

Nov 9, 2022

First Posted Date

Nov 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2023

Last Update Posted Date

Dec 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

410Actual

Name	Type	Description	Arm Group Labels	Other Names
Kidney Transplantation	Other	Kidney transplantation

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Immunosuppressants prescribed at discharge	Immunosuppressive medication at discharge after transplant	2 weeks
Number of infections	Viral infections after transplantations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All pediatric kidney recipients that were transplanted in one of the participating centers and followed up for at least one month

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Medical Center		Nijmegen		6500HB	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Researchers from centers that contributed can request anonymized data

Types

Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016030	Kidney Transplantation

Ancestor Terms

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016377	Organ Transplantation
D014180	Transplantation

Browse Leaves

Not provided

Browse Branches

Not provided