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Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques (TUIKIT)

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ClinicalTrials.gov Identifier: NCT05397821
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : December 5, 2023
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Radboud University Medical Center

Tracking Information
First Submitted Date May 25, 2022
First Posted Date May 31, 2022
Last Update Posted Date December 5, 2023
Actual Study Start Date June 1, 2023
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2022)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 25, 2022)		 Graft survival [ Time Frame: 25 years ]
Percentage of patients with a functioning graft
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques
Official Title The Optimal Method for Ureter Implantation in Pediatric Kidney Transplantation
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric kidney recipients that were transplanted between 1994-2018 in either Radboudumc or Winconsin University
Condition
  • Kidney Transplant; Complications
  • Kidney Transplant Infection
  • Kidney Transplant Failure and Rejection
Intervention Procedure: UNC technique
In general, UNC techniques can be divided in being either intravesical or extravesical and refluxing or non-refluxing
Study Groups/Cohorts
  • Radboudumc recipients
    NTX performed with a refluxing technique
    Intervention: Procedure: UNC technique
  • Winsconsin recipients
    NTX performed with a non-refluxing technique
    Intervention: Procedure: UNC technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 25, 2022)		 398
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Loss of follow up < 1 year
Sex/Gender
Sexes Eligible for Study: All
Ages 0 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Loes Oomen, MD +31613971379 loes.oomen@radboudumc.nl
Contact: David Lamers, MD +31654325496 David.Lamers@radboudumc.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT05397821
Other Study ID Numbers 112452
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: On request
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 25 year
Access Criteria: well written request
Current Responsible Party Radboud University Medical Center
Original Responsible Party Same as current
Current Study Sponsor Radboud University Medical Center
Original Study Sponsor Same as current
Collaborators University of Wisconsin, Madison
Investigators
Principal Investigator: Liesbeth Lamers, MD Radboud University Medical Center
PRS Account Radboud University Medical Center
Verification Date December 2023