Respiratory Tract DiseaseSPIROKIDNCT03571542
Evaluation of the Respiratory Function in Renal Transplanted Children
A study testing pulmonary function in people with Respiratory Tract Disease and Kidney Transplantation, run by Nantes University Hospital at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Respiratory Tract Disease, Kidney Transplantation, Pediatric
- What is being tested?
- pulmonary function
- How many people
- 385 participants
- Where
- 5 sitesFrance
- Study dates
- 16 Jul 2018to 16 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Renal transplanted
- Patients of 2 to 20 years old
- Followed in one the five centers mentionned above (Nantes, Necker, Robert Debré, Lyon, Lille)
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHRU Lille
Lille
Robert NOVO
- Recruiting
Hospices Civiles de Lyon
Lyon
Anne-Laure SELLIER
- Recruiting
CHU de Nantes
Nantes
Alexandra BRUEL, Dr
- Recruiting
Hôpital Universitaire Necker Enfants Malades
Paris
Laurène DEHOUX
- Recruiting
Robert Debre Hospital
Paris
Véronique BAUDOUIN, Dr
About this study
Official title: Evaluation of the Respiratory Function in Renal Transplanted Children : a Prospective, Multicenter French Study
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.
Read more
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
- Being tested
- pulmonary function
- Keywords
- Children, transplanted, kidney transplantation, respiratory function, pulmonary function tests, respiratory disease, immunosuppression
- Medical subject headings
- Respiratory Tract Diseases, Respiratory Aspiration, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary functionOther
The aim of this study is to assess the respiratory function thanks to pulmonary function tests in renal transplanted children in France.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory alteration
An alteration of the pulmonary function tests (PFT) values or the presence of chronic respiratory symptoms/treatment (questionnaire)
Measured: at the inclusion
Secondary outcomes (1)
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).
Measured: at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start16 Jul 2018
- Primary completion16 Jul 2022 (estimated)
- Study completion16 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Hospices Civils de Lyon, Hôpital Necker-Enfants Malades, Hopital Universitaire Robert-Debre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571542
- Sponsor's protocol ID
- RC18_0142
- Acronym
- SPIROKID
- Status last verified
- Jun 2021
- First submitted
- 31 May 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Respiratory Function in Renal Transplanted Children : a Prospective, Multicenter French Study
- ClinicalTrials.gov ID
- NCT03571542
- Acronym / sponsor ID
- SPIROKID / RC18_0142
- Conditions
- Respiratory Tract Disease, Kidney Transplantation, Pediatric
- Keywords
- Children, transplanted, kidney transplantation, respiratory function, pulmonary function tests, respiratory disease, immunosuppression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Hospices Civils de Lyon, Hôpital Necker-Enfants Malades, Hopital Universitaire Robert-Debre
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 16 Jul 2022 (estimated)
- Study completion
- 16 Jul 2022 (estimated)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Renal transplanted
- Patients of 2 to 20 years old
- Followed in one the five centers mentionned above (Nantes, Necker, Robert Debré, Lyon, Lille)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary functionThe aim of this study is to assess the respiratory function thanks to pulmonary function tests in renal transplanted children in France. | Other | – |
Primary outcome
Respiratory alteration
Time frame: at the inclusion
An alteration of the pulmonary function tests (PFT) values or the presence of chronic respiratory symptoms/treatment (questionnaire)
1 secondary outcome
risk factors linked to an alteration of the respiratory function
Time frame: at the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary function in people with Respiratory Tract Disease and Kidney Transplantation, run by Nantes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra BRUEL (0240083566, alexandra.bruel@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory alteration (time frame: at the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.