End Stage Renal Disease Clinical Trial
— PeKiTOfficial title:
Pediatric Kidney Transplant
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Imagine Institute |
France,
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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