ClinicalTrials.gg
Status unknownNCT05977387PeKiTUpdated Aug 4, 2023

Pediatric Kidney Transplant

An observational study in End Stage Renal Disease, Pediatric ALL and Kidney Transplant; Complications, sponsored by Imagine Institute. Status unknown at 4 sites in France. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Imagine Institute · Observational

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
0 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • End Stage Renal Disease
  • Pediatric ALL
  • Kidney Transplant; Complications
03

In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

This study's planned enrollment of 500 is above the median of 120 across 441 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Imagine Institute is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients from 0 to 18 years who underwent renal transplant for ESRD

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Multi organ transplant
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 years

Secondary outcomes

  1. Surgical complications

    Evaluate the surgical morbidity of renal transplantation

    Time frame: 10 years

  2. Graft Survival

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

    Time frame: 10 years

  3. Return to dialysis

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

    Time frame: 10 years

  4. Retransplantation

    Evaluation the number of patient undegoing another transplantation

    Time frame: 10 years

  5. Death

    Evaluation of the morbidity of this population

    Time frame: 10 years

07

Study locations

4 of 4 sites recruiting
  • l'hôpital mère-enfant de Lyon
    Bron, France
    • Thomas Blanc, Pr · Contact
    Recruiting
  • l'hôpital mère enfant de Nantes
    Nantes, France
    • Thomas Leblanc, Pr · Contact
    Recruiting
  • l'hôpital Robert Debré
    Paris, 75019, France
    Recruiting
  • l'hôpital Necker Enfants malades.
    Paris, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2021 (actual). Primary completion is estimated for Jun 2024, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2022
First posted
Aug 4, 2023
StartActual
Oct 1, 2021
Primary completionEst.
Jun 30, 2024
CompletionEst.
Jun 30, 2024
Last update
Aug 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05977387
Lead sponsor
Imagine Institute
Responsible party
Sponsor
First posted
Aug 4, 2023
Start date
Oct 1, 2021
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Aug 4, 2023

Study contacts

Thomas Blanc, Pr
Contact
thomas.blanc@aphp.fr
+ 33 1 44 49 41 86

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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