Evaluation of the Respiratory Function in Renal Transplanted Children

Kidney Transplantation Clinical Trial

— SPIROKID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571542
• Other study ID #: RC18_0142
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: July 16, 2022

Study information

• Verified date: June 2021
• Source: Nantes University Hospital
• Contact: Alexandra BRUEL
• Phone: 0240083566
• Email: alexandra.bruel[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 385
• Est. completion date: July 16, 2022
• Est. primary completion date: July 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Transplantation
• Pediatric
• Respiratory Tract Disease
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
France	CHRU Lille	Lille
France	Hospices Civiles de Lyon	Lyon
France	CHU de Nantes	Nantes
France	Hôpital Universitaire Necker Enfants Malades	Paris
France	Robert Debre Hospital	Paris

Sponsors (5)

Lead Sponsor	Collaborator
Nantes University Hospital	Hospices Civils de Lyon, Lille University Hospital, NECKER UNIVERSITY HOSPITAL, Robert Debré Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory alteration	An alteration of the pulmonary function tests (PFT) values or the presence of chronic respiratory symptoms/treatment (questionnaire)	at the inclusion
Secondary	risk factors linked to an alteration of the respiratory function	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).	at the inclusion