PeKiT: Pediatric Kidney Transplant

Sponsor
Imagine Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05977387
Collaborator
(none)
500
4
33
125
3.8

Study Details

Study Description

Brief Summary

End-stage renal disease (ESRD) is a rare disease in children. Renal transplantation (RT) is the treatment of choice for ESRD in the pediatric population. In France, around 100 pediatric kidney transplants are performed each year. The aim was to evaluate the surgical management of TR and the long-term results.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    End-stage renal disease (ESRD) is a rare pathology in children, whose gold standard treatment is a kidney transplant. In France, around 100 pediatric kidney transplants are performed every year.

    Although the first adult kidney transplants were performed in 1954, pediatric renal transplantation was considered unsafe compared with dialysis, which was preferred. In the 1980s, improved graft selection, optimized pre-transplant management and a better understanding of the immune system led to the development of pediatric kidney transplantation.

    Despite considerable progress, graft survival in these long-lived patients remains a major challenge.

    The aim of this study is to evaluate surgical practices in the four French pediatric transplant centers, and to define risk factors for surgical complications.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Pediatric Kidney Transplant
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Surgical outcomes [10 years]

      To assess surgical outcome in pediatric renal transplantation in terms of per operative complications (ClassIntra classification) post operative complications (Clavien Dindo) early < 30 days and late > 30 days

    Secondary Outcome Measures

    1. Surgical complications [10 years]

      Evaluate the surgical morbidity of renal transplantation

    2. Graft Survival [10 years]

      Evaluate graft survival at 1, 5 and 10 years post transplantation

    3. Return to dialysis [10 years]

      Evaluation of the need to return to dialysis after transplantation : causes and reasons

    4. Retransplantation [10 years]

      Evaluation the number of patient undegoing another transplantation

    5. Death [10 years]

      Evaluation of the morbidity of this population

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All pediatric patients who underwent renal transplantation in one of the 4 centers
    Exclusion Criteria:
    • Multi organ transplant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 l'hôpital mère-enfant de Lyon Bron France
    2 l'hôpital mère enfant de Nantes Nantes France
    3 l'hôpital Robert Debré Paris France 75019
    4 l'hôpital Necker Enfants malades. Paris France

    Sponsors and Collaborators

    • Imagine Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imagine Institute
    ClinicalTrials.gov Identifier:
    NCT05977387
    Other Study ID Numbers:
    • HJ-21-PeKiT
    First Posted:
    Aug 4, 2023
    Last Update Posted:
    Aug 4, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2023