Evaluation of the Respiratory Function in Renal Transplanted Children

Not Applicable

• Conditions: Respiratory Tract Disease; Kidney Transplantation; Pediatric

• Registration Number: NCT03571542
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-27
• Study Start: 2018-07-16
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-18
• Primary Completion: 2022-07-16
• Study Completion: 2022-07-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 385

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)

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (5)

CHRU Lille; 🇫🇷 Lille, France

Hospices Civiles de Lyon; 🇫🇷 Lyon, France

Robert Debre Hospital; 🇫🇷 Paris, France

Hôpital Universitaire Necker Enfants Malades; 🇫🇷 Paris, France

CHU de Nantes; 🇫🇷 Nantes, France