NCT05977387

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

2.7 years

First QC Date

February 8, 2022

Last Update Submit

August 2, 2023

Conditions

End Stage Renal DiseasePediatric ALLKidney Transplant; Complications

Outcome Measures

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

    10 years

Secondary Outcomes (5)

  • Surgical complications

    10 years

  • Graft Survival

    10 years

  • Return to dialysis

    10 years

  • Retransplantation

    10 years

  • Death

    10 years

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Multi organ transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

l'hôpital mère-enfant de Lyon

Bron, France

RECRUITING

l'hôpital mère enfant de Nantes

Nantes, France

RECRUITING

l'hôpital Robert Debré

Paris, 75019, France

RECRUITING

l'hôpital Necker Enfants malades.

Paris, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Thomas Blanc, Pr

CONTACT

+ 33 1 44 49 41 86thomas.blanc@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

August 4, 2023

Study Start

October 1, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations

FR(4)