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Evaluation of the Respiratory Function in Renal Transplanted Children

Evaluation of the Respiratory Function in Renal Transplanted Children : a Prospective, Multicenter French Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03571542
Acronym
SPIROKID
Enrollment
385
Registered
2018-06-27
Start date
2018-07-16
Completion date
2022-07-16
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, Pediatric, Respiratory Tract Disease

Keywords

Children, transplanted, kidney transplantation, respiratory function, pulmonary function tests, respiratory disease, immunosuppression

Brief summary

Objectives: While a respiratory abnormality was found in 50% of pediatric renal transplant recipients in a study conducted in Belgium and the Netherlands in 2008, the respiratory status of transplanted children in France remains unknown. The primary objective of this study is to assess the prevalence of respiratory impairment and its characteristics in children with renal transplant. The secondary objective is to study its association with some potential risk factors such as immunosuppressive therapy or humoral immunodeficiency. Methodology: This interventional study aims to recruit the 385 children currently being followed by 5 French pediatric renal transplant centers between June 2018 and November 2019. A clinical and functional respiratory assessment will be carried out during the routine annual follow-up of the transplant recipient. Children with clinical signs of concern or abnormal spirometry will be referred to a respiratory specialist. Pharmacokinetic assays of immunosuppressant therapy and the exploration of humoral function will also be performed. The prevalence and type of respiratory abnormalities will be described. Logistic regression will be used to explore the association between potential risk factors and impaired respiratory function. Expected results: This study will be the first to evaluate the respiratory status of children with renal transplants in France. The prospective, multi- centered nature of the study, in addition to the large cohort size (which represents two thirds of children with renal transplants in France) will guarantee current, reliable, and representative data for the target population. We will provide new knowledge by precisely characterizing the type of lung injury and looking for potential risk factors. If our study confirms the high prevalence of pulmonary impairment in children with renal transplants, systematic monitoring of respiratory function may be recommended to enable early diagnosis and management. The expected individual and public health benefits would be significant by limiting the appearance of long-term, irreversible sequelae (such as non-cystic-fibrosis bronchiectasis) and improving the quality of life of these patients.

Interventions

OTHERpulmonary function

The aim of this study is to assess the respiratory function thanks to pulmonary function tests in renal transplanted children in France.

Sponsors

Lille University Hospital
CollaboratorUNKNOWN
Hospices Civils de Lyon
CollaboratorOTHER
NECKER UNIVERSITY HOSPITAL
CollaboratorUNKNOWN
Hopital Universitaire Robert-Debre
CollaboratorOTHER
Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

* Renal transplanted * Patients of 2 to 20 years old * Followed in one the five centers mentionned above (Nantes, Necker, Robert Debré, Lyon, Lille)

Exclusion criteria

* Disaggrement from the patient and/or his/her legal representant * Impossibility to do the pulmonary function test * Cystic fibrosis * Patient with another transplant (heart, lung, liver)

Design outcomes

Primary

MeasureTime frameDescription
Respiratory alterationat the inclusionAn alteration of the pulmonary function tests (PFT) values or the presence of chronic respiratory symptoms/treatment (questionnaire)

Secondary

MeasureTime frameDescription
risk factors linked to an alteration of the respiratory functionat the inclusionWe will analyse the relation between several exposure variables or the potential risk factors (medical past, medication, infectious diseases,...) and the presence of an alteration of the respiratory function. Clinical datas will be gathered thanks to a questionnaire on the medical past and the respiratory state of the child. The usual biological measures will be done at the annual check up (exploring immunity, pharmacological dosages, renal function, for example).

Countries

France

Contacts

Primary ContactAlexandra BRUEL
alexandra.bruel@chu-nantes.fr0240083566
Backup ContactTiphaine BIHOUEE
tiphaine.bihouee@chu-nantes.fr0240083333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026