Pediatric Kidney Transplant

Recruiting

• Conditions: End Stage Renal Disease; Pediatric ALL; Kidney Transplant; Complications

• Registration Number: NCT05977387
• Lead Sponsor: Imagine Institute

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.

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 Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-02-08
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All pediatric patients who underwent renal transplantation in one of the 4 centers

Exclusion Criteria

• Multi organ transplant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Retransplantation	10 years	Evaluation the number of patient undegoing another transplantation
Surgical complications	10 years	Evaluate the surgical morbidity of renal transplantation
Return to dialysis	10 years	Evaluation of the need to return to dialysis after transplantation : causes and reasons
Death	10 years	Evaluation of the morbidity of this population
Graft Survival	10 years	Evaluate graft survival at 1, 5 and 10 years post transplantation

Trial Locations

Locations (4)

l'hôpital mère-enfant de Lyon; 🇫🇷 Bron, France

l'hôpital mère enfant de Nantes; 🇫🇷 Nantes, France

l'hôpital Robert Debré; 🇫🇷 Paris, France

l'hôpital Necker Enfants malades.; 🇫🇷 Paris, France