Kidney Transplant FailureNCT05619679
A Clinical Practice Snapshot on Pediatric Kidney Transplantation
An observational study of Kidney Transplant Failure, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Kidney Transplant Failure
- What is being tested?
- Kidney Transplantation
- How many people
- 410 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2022to 30 Jun 2023
- 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
- Child, Adult
Study population: All pediatric kidney recipients that were transplanted in one of the participating centers and followed up for at least one month
Who may be able to join
- Kidney received <18 years
- at least one month of follow-up
- transplantation and follow-up in dedicated PKT center
Who cannot join
- combined transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplant Failure
- Being tested
- Kidney Transplantation
- Keywords
- Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney TransplantationOther
Kidney transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Functioning graft
Measured: at end of follow-up at least one month
Donor type
Living or deceased donor
Measured: At transplantation
Secondary outcomes (2)
Immunosuppressants prescribed at discharge
Immunosuppressive medication at discharge after transplant
Measured: 2 weeks
Number of infections
Viral infections after transplantations
Measured: end of follow-up, at least one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start10 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant FailureStudies 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
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619679
- Sponsor's protocol ID
- PKT.Clinical.Snapshot
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers from centers that contributed can request anonymized data
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Practice Snapshot on Pediatric Kidney Transplantation Healthcare in Europe
- ClinicalTrials.gov ID
- NCT05619679
- Acronym / sponsor ID
- PKT.Clinical.Snapshot
- Conditions
- Kidney Transplant Failure
- Keywords
- Kidney transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Nov 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All pediatric kidney recipients that were transplanted in one of the participating centers and followed up for at least one month
Key inclusion criteria (3 listed)
- Kidney received <18 years
- at least one month of follow-up
- transplantation and follow-up in dedicated PKT center
Key exclusion criteria (1 listed)
- combined transplantation
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 |
|---|---|---|
| Kidney TransplantationKidney transplantation | Other | – |
Primary outcome
Graft survival
Time frame: at end of follow-up at least one month
Functioning graft
Donor type
Time frame: At transplantation
Living or deceased donor
2 secondary outcomes
Immunosuppressants prescribed at discharge
Time frame: 2 weeks
Number of infections
Time frame: end of follow-up, at least one month
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 5 Dec 2023.
- Individual participant dataSharing planned: Yes. Researchers from centers that contributed can request anonymized data
Related trials for Kidney Transplant Failure
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection
RecruitingPhase 1
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
End Stage Renal Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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: at end of follow-up at least one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2023.