Kidney Transplant; ComplicationsTUIKITNCT05397821
Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques
An observational study of Kidney Transplant; Complications and Kidney Transplant Infection, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Kidney Transplant; Complications, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
- What is being tested?
- UNC technique
- Type of treatment
- Surgery or procedure
- How many people
- 398 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2023to Nov 2024
- 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
- No healthy volunteers
- Child, Adult
Study population: Pediatric kidney recipients that were transplanted between 1994-2018 in either Radboudumc or Winconsin University
Who may be able to join
- received kidney graft in the participating centres at an age <19
- received kidney graft between 1994-2018
- follow-up data of at least 1 year
Who cannot join
- Loss of follow up < 1 year
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, 6500HB
Loes Oomen, +31613971379, loes.oomen@radboudumc.nl
About this study
Official title: The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation
In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction.
Read the detailed description
Multi-center retrospective study and survey on clinical practice among different urologists. The researchers will retrospectively study data on patients that received their kidney graft between 1994-2018 in either Radboudumc or UW Health University Hospital in Winsconsin.
Additionally, all urologist currently employed at those hospitals will be asked to fill in a survey on preferences in UNC techniques and suture material.
- Conditions
- Kidney Transplant; Complications, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
- Being tested
- UNC technique
- Keywords
- Kidney transplantation, Pediatrics
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNC techniqueProcedure or surgery
In general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing
| Study group | Role | What they receive |
|---|---|---|
| Radboudumc recipients | NTX performed with a refluxing technique Receives: Procedure: UNC technique | |
| Winsconsin recipients | NTX performed with a non-refluxing technique Receives: Procedure: UNC technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infections
Number of urinary tract infections (with fever)
Measured: 25 year
Ureteral obstruction
Number of ureteral obstruction needing intervention
Measured: 25 year
Secondary outcomes (1)
Graft survival
Percentage of patients with a functioning graft
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jun 2023
- Primary completionJul 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- 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
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Liesbeth Lamers, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397821
- Sponsor's protocol ID
- 112452
- Acronym
- TUIKIT
- Status last verified
- Dec 2023
- First submitted
- 25 May 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: On request
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
- The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05397821
- Acronym / sponsor ID
- TUIKIT / 112452
- Conditions
- Kidney Transplant; Complications, Kidney Transplant Infection, Kidney Transplant Failure and Rejection
- Keywords
- Kidney transplantation, Pediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 31 May 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.
In this study the researchers want to retrospectively compare non-refluxing ureteroneocystostomy (UNC techniques to reflux UNC techniques in paediatric kidney recipients with regard to urinary tract infections and uteral obstruction.
Detailed description
Multi-center retrospective study and survey on clinical practice among different urologists. The researchers will retrospectively study data on patients that received their kidney graft between 1994-2018 in either Radboudumc or UW Health University Hospital in Winsconsin.
Additionally, all urologist currently employed at those hospitals will be asked to fill in a survey on preferences in UNC techniques and suture material.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radboudumc recipients | – | Procedure: UNC techniqueNTX performed with a refluxing technique |
| Winsconsin recipients | – | Procedure: UNC techniqueNTX performed with a non-refluxing technique |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric kidney recipients that were transplanted between 1994-2018 in either Radboudumc or Winconsin University
Key inclusion criteria (3 listed)
- received kidney graft in the participating centres at an age <19
- received kidney graft between 1994-2018
- follow-up data of at least 1 year
Key exclusion criteria (1 listed)
- Loss of follow up < 1 year
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 |
|---|---|---|
| UNC techniqueIn general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing | Procedure or surgery | Radboudumc recipients, Winsconsin recipients |
Primary outcome
Urinary tract infections
Time frame: 25 year
Number of urinary tract infections (with fever)
Ureteral obstruction
Time frame: 25 year
Number of ureteral obstruction needing intervention
1 secondary outcome
Graft survival
Time frame: 25 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Yes. On request
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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.
Liesbeth Lamers, MD principal investigator
Radboud University Medical Center
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; Complications and Kidney Transplant Infection, 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loes Oomen, MD (+31613971379, loes.oomen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infections (time frame: 25 year). 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.