SPIROKID: Evaluation of the Respiratory Function in Renal Transplanted Children

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03571542

Collaborator

Lille University Hospital (Other), Hospices Civils de Lyon (Other), NECKER UNIVERSITY HOSPITAL (Other), Hopital Universitaire Robert-Debre (Other)

385

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Tract Disease Kidney Transplantation Pediatric	Other: pulmonary function	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

385 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 16, 2018

Anticipated Primary Completion Date :

Jul 16, 2022

Anticipated Study Completion Date :

Jul 16, 2022

Outcome Measures

Primary Outcome Measures

Respiratory alteration [at the inclusion]
An alteration of the pulmonary function tests (PFT) values or the presence of chronic respiratory symptoms/treatment (questionnaire)

Secondary Outcome Measures

risk factors linked to an alteration of the respiratory function [at the inclusion]
We 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country
1	CHRU Lille	Lille	France
2	Hospices Civiles de Lyon	Lyon	France
3	CHU de Nantes	Nantes	France
4	Hôpital Universitaire Necker Enfants Malades	Paris	France
5	Robert Debre Hospital	Paris	France