Evaluation of the Respiratory Function in Renal Transplanted Children

NCT03571542 | Unknown

• 1 other identifier: RC18_0142
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 5

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.

Conditions

Respiratory Tract Disease; Kidney Transplantation; Pediatric

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Respiratory alteration

  An alteration of the pulmonary function tests (PFT) values or the presence of chronic respiratory symptoms/treatment (questionnaire)

  at the inclusion

Secondary Outcomes (1)

• risk factors linked to an alteration of the respiratory function

  at the inclusion

Interventions

pulmonary function OTHER

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

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead
• Lille University Hospital: collaborator
• Hospices Civils de Lyon: collaborator
• NECKER UNIVERSITY HOSPITAL: collaborator
• Hopital Universitaire Robert-Debre: collaborator

Study Sites (5)

CHRU Lille

Lille, France

RECRUITING

Hospices Civiles de Lyon

Lyon, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

Hôpital Universitaire Necker Enfants Malades

Paris, France

RECRUITING

Robert Debre Hospital

Paris, France

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Diseases; Respiratory Aspiration; Respiration Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandra BRUEL

CONTACT

0240083566; alexandra.bruel@chu-nantes.fr

Tiphaine BIHOUEE

CONTACT

0240083333; tiphaine.bihouee@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 27, 2018
• Study Start: July 16, 2018
• Primary Completion: July 16, 2022
• Study Completion: July 16, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

FR (5)