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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49088

Enrollment

200

Registered

2020-07-27

Start date

2020-08-19

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Intestitial lung disease lung fibrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • Unable to draw blood for study purposes

Design outcomes

Primary

Measure	Time frame
- To correlate PK parameters of nintedanib with its efficacy and toxicity in patients with ILD.	—

Secondary

Measure	Time frame
- To correlate PK parameters of nintedanib with its toxicity. - To determine the influence of other variables, e.g. comedication, genetics, or food on nintedanib PK. - To develop a population pharmacokinetic model of nintedanib	—

Countries

Netherlands

Outcome results