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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05977387
Other study ID # HJ-21-PeKiT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date June 30, 2024

Study information

Verified date August 2023
Source Imagine Institute
Contact Thomas Blanc, Pr
Phone + 33 1 44 49 41 86
Email thomas.blanc@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility Inclusion Criteria: - All pediatric patients who underwent renal transplantation in one of the 4 centers Exclusion Criteria: - Multi organ transplant

Study Design


Locations

Country Name City State
France l'hôpital mère-enfant de Lyon Bron
France l'hôpital mère enfant de Nantes Nantes
France l'hôpital Necker Enfants malades. Paris
France l'hôpital Robert Debré Paris

Sponsors (1)

Lead Sponsor Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgical outcomes 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
10 years
Secondary Surgical complications Evaluate the surgical morbidity of renal transplantation 10 years
Secondary Graft Survival Evaluate graft survival at 1, 5 and 10 years post transplantation 10 years
Secondary Return to dialysis Evaluation of the need to return to dialysis after transplantation : causes and reasons 10 years
Secondary Retransplantation Evaluation the number of patient undegoing another transplantation 10 years
Secondary Death Evaluation of the morbidity of this population 10 years
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