Correlating plasma nintedanib concentrations with clinical outcome and toxicity in patients with interstitial lung disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25641

Enrollment

200

Registered

2020-09-16

Start date

2020-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Age 18 years or older; • Able to understand the written Information and able to give informed consent; • Planned treatment with nintedanib for any fibrotic ILD according to standard of care.

Exclusion criteria

Exclusion criteria: A potential subject who is unable to draw blood for study purposes will be excluded.

Design outcomes

Primary

Measure	Time frame
Pharnnacokinetics - i.e. trough levels - of nintedanib and clinical outcome {e.g. lung function and frequency of exacerbations)	—

Secondary

Measure	Time frame
- Toxicity of nintedanib - Nintedanib dose and treatment duration - Frequency and type of other variables that could influence nintedanib PK, e.g. comedication, genetic variances in drug metabolizing (CYP) enzymes and drug transporters, and food (supplements).	—

Contacts

Public ContactG.D. Marijn Veerman

Erasmus MC

g.veerman@erasmusmc.nl0641531792

Outcome results