Pediatric Kidney Transplant (PeKiT)

August 2, 2023 updated by: Imagine Institute
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France
        • Recruiting
        • l'hôpital mère-enfant de Lyon
        • Contact:
          • Thomas Blanc, Pr
      • Nantes, France
        • Recruiting
        • l'hôpital mère enfant de Nantes
        • Contact:
          • Thomas Leblanc, Pr
      • Paris, France, 75019
        • Recruiting
        • l'hôpital Robert Debré
        • Contact:
      • Paris, France
        • Recruiting
        • l'hôpital Necker Enfants malades.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Multi organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical outcomes
Time Frame: 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
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imagine Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJ-21-PeKiT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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