Longitudinal Changes in Serum KL-6 in IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

— LOCK-IPF  

Official title:

Longitudinal Changes in Serum KL-6 Levels in Idiopathic Pulmonary Fibrosis (LOCK-IPF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04268485
• Other study ID #: ManchesterUNHS
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Manchester University NHS Foundation Trust
• Contact: Conal Hayton, MBChB
• Phone: +441612915388
• Email: conalhayton[@]doctors.org.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. More accurate tests to predict disease progression and response to treatment are required.

Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.

The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood.

Description:

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. Effective treatment which slows the progression of IPF has recently become available however, it is costly and at present is limited to patients who meet specific criteria based on their breathing tests. The breathing tests currently available to monitor progression of the disease are not always reliable and do not predict which patients will respond to treatment. More accurate tests to predict disease progression and response to treatment are required.

Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. The majority of studies using KL-6 in IPF have taken place in Japan and there is limited evidence of how useful it is in a European population. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.

The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood

The objective of this study is to assess changes in serum KL-6 levels in patients with IPF over a 12-month period and assess if this correlates with changes in lung function and if KL-6 levels change in response to treatment with antifibrotic therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Multi-disciplinary team (MDT) diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines

Exclusion criteria

• Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not IPF)

• FEV1/FVC ratio < 70% on full lung function testing

• Current smoker (within 4 week of enrollment)

• Received treatment for acute lower respiratory tract infection with last 4 weeks

• Use of long-term (greater than 4 weeks) oral corticosteroids or immunosuppression within 4 weeks of enrolment

• Current participation in a double-blind placebo-controlled pharmaceutical trial

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Diagnostic Test:
• Serum KL-6 level
Serum blood biomarker which has been shown to be of interest in idiopathic pulmonary fibrosis

Locations

Country	Name	City	State
United Kingdom	Manchester University hospitals NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum KL-6 level	Change in serum KL-6 level between baseline and 12 months	12 months
Secondary	Serum KL-6 level at 3, 6 months	Change in serum KL-6 at 3 and 6 months compared to baseline	3 and 6 months
Secondary	KL-6 forced vital capacity (FVC) correlation	Correlation of KL-6 and FVC change at 3, 6 and 12 months	3, 6 and12 months
Secondary	KL-6 diffusion capacity (DLCO)	Correlation of KL-6 and DLCO change at 3, 6 and 12 months	3, 6 and12 months
Secondary	KL-6 symptoms	Correlation of KL-6 and symptom scores at 3, 6 and 12 months	3, 6 and12 months
Secondary	KL-6 antifibrotics	Change in KL-6 levels in response to antifibrotic therapy	12 months
Secondary	KL-6 Gender Age and Physiology (GAP) stage	Differences in KL-6 levels between Gender Age Physiology (GAP) stage at baseline	At baseline
Secondary	KL-6 CPI	Correlation between KL-6 levels and Composite Physiology Index (CPI)	At baseline
Secondary	KL-6 CT pattern	Difference in KL-6 levels between patients with indeterminate, probable and definite usual interstitial pneumonia pattern (UIP) on HRCT	At baseline