COrrelating plasma Nintedanib COncentRations with efficacy and toxicity in patients with interstitial lung DIseAse

Phase 4

Completed

• Conditions: Intestitial lung disease; lung fibrosis; 10024967

• Registration Number: NL-OMON49088
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

• Age >=18 years;
• Able to understand the written information and able to give informed consent;
• Planned treatment with nintedanib for any fibrotic interstitial lung disease
according to standard of care.

Exclusion Criteria

• Unable to draw blood for study purposes

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To correlate PK parameters of nintedanib with its efficacy and toxicity in<br /><br>patients with ILD. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To correlate PK parameters of nintedanib with its toxicity.<br /><br>- To determine the influence of other variables, e.g. comedication, genetics,<br /><br>or food on nintedanib PK.<br /><br>- To develop a population pharmacokinetic model of nintedanib</p><br>