Clinical trial NCT03571542: Evaluation of the Respiratory Function in Renal Transplanted Children
Official title: Evaluation of the Respiratory Function in Renal Transplanted Children : a Prospective, Multicenter French Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Tract Disease
Kidney Transplantation
Pediatric
Keywords: Children
transplanted
kidney transplantation
respiratory function
pulmonary function tests
respiratory disease
immunosuppression
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Lille University Hospital
name: Hospices Civils de Lyon
name: NECKER UNIVERSITY HOSPITAL
name: Hopital Universitaire Robert-Debre
First posted: 2018-06-27
Enrollment: 385
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Respiratory alteration
timeFrame: at the inclusion
Secondary outcomes:
measure: risk factors linked to an alteration of the respiratory function
timeFrame: at the inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hospices Civiles de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Universitaire Necker Enfants Malades
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
References: