End Stage Renal DiseasePeKiTNCT05977387
Pediatric Kidney Transplant
An observational study of End Stage Renal Disease and Pediatric ALL, run by Imagine Institute at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- End Stage Renal Disease, Pediatric ALL, Kidney Transplant; Complications
- How many people
- 500 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2021to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients from 0 to 18 years who underwent renal transplant for ESRD
Who may be able to join
- All pediatric patients who underwent renal transplantation in one of the 4 centers
Who cannot join
- Multi organ transplant
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
l'hôpital mère-enfant de Lyon
Bron
Thomas Blanc, Pr
- Recruiting
l'hôpital mère enfant de Nantes
Nantes
Thomas Leblanc, Pr
- Recruiting
l'hôpital Robert Debré
Paris, 75019
Thomas Blanc, Pr, + 33 1 44 49 41 86, thomas.blanc@aphp.fr
- Recruiting
l'hôpital Necker Enfants malades.
Paris
Thomas Blanc, Pr, + 33 1 44 49 41 86, thomas.blanc@aphp.fr
About this study
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.
- Medical subject headings
- Kidney Failure, Chronic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (5)
Surgical complications
Evaluate the surgical morbidity of renal transplantation
Measured: 10 years
Graft Survival
Evaluate graft survival at 1, 5 and 10 years post transplantation
Measured: 10 years
Return to dialysis
Evaluation of the need to return to dialysis after transplantation : causes and reasons
Measured: 10 years
Retransplantation
Evaluation the number of patient undegoing another transplantation
Measured: 10 years
Death
Evaluation of the morbidity of this population
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Oct 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977387
- Sponsor's protocol ID
- HJ-21-PeKiT
- Acronym
- PeKiT
- Status last verified
- Aug 2023
- First submitted
- 8 Feb 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Kidney Transplant
- ClinicalTrials.gov ID
- NCT05977387
- Acronym / sponsor ID
- PeKiT / HJ-21-PeKiT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients from 0 to 18 years who underwent renal transplant for ESRD
Key inclusion criteria (1 listed)
- All pediatric patients who underwent renal transplantation in one of the 4 centers
Key exclusion criteria (1 listed)
- Multi organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Surgical complications
Time frame: 10 years
Graft Survival
Time frame: 10 years
Return to dialysis
Time frame: 10 years
Retransplantation
Time frame: 10 years
Death
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Pediatric ALL, run by Imagine Institute at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Blanc, Pr (+ 33 1 44 49 41 86, thomas.blanc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical outcomes (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.