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ID
Source
Brief title
Health condition
Interstitial lung disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Penetration rate of nintedanib in different types of lung tissue.
Secondary outcome
Variability in nintedanib concentrations
Background summary
Nintedanib is a small-molecule kinase inhibitor used for treating fibrotic interstitial lung disease (fILD) and lung cancer. The exposure to and distribution in lung tissue of nintedanib is unknown. Hence this study aims to quantify the nintedanib concentrations in normal, fibrotic and borderline-fibrotic lung tissue in fILD patients who underwent a lung transplantation and were treated with nintedanib until transplantation.
Study objective
Higher concentration nintedanib in normal lung tissue compared to fibrotic lung tissue.
Study design
Full analysis of primary and secondary endpoints after last evaluable inclusion. Drug concentrations are measured with LC/MS-MS.
Inclusion criteria
Patients treated with nintedanib until lung transplantation
Exclusion criteria
Unwilling to sign informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8912 |
| Other | METC Erasmus MC : MEC 19-291 |