Pediatric Kidney Transplant

End Stage Renal Disease Clinical Trial

— PeKiT  

Official title:

Pediatric Kidney Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977387
• Other study ID #: HJ-21-PeKiT
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Kidney Transplant; Complications
• Pediatric ALL

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