- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268485
Longitudinal Changes in Serum KL-6 in IPF (LOCK-IPF)
Longitudinal Changes in Serum KL-6 Levels in Idiopathic Pulmonary Fibrosis (LOCK-IPF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Conal Hayton, MBChB
- Phone Number: +441612915388
- Email: conalhayton@doctors.org.uk
Study Contact Backup
- Name: Nazia Chaudhuri
- Phone Number: +441612915054
- Email: nazia.chaudhuri@mft.nhs.uk
Study Locations
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Manchester, United Kingdom
- Recruiting
- Manchester University Hospitals NHS Foundation Trust
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Contact:
- Conal Hayton
- Email: conal.hayton@mft.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IPF patients
Patients with an MDT diagnosis of idiopathic pulmonary fibrosis.
Patients will be observed over a 12 month period and have serial serum samples taken for KL-6 level.
|
Serum blood biomarker which has been shown to be of interest in idiopathic pulmonary fibrosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum KL-6 level
Time Frame: 12 months
|
Change in serum KL-6 level between baseline and 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum KL-6 level at 3, 6 months
Time Frame: 3 and 6 months
|
Change in serum KL-6 at 3 and 6 months compared to baseline
|
3 and 6 months
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KL-6 forced vital capacity (FVC) correlation
Time Frame: 3, 6 and12 months
|
Correlation of KL-6 and FVC change at 3, 6 and 12 months
|
3, 6 and12 months
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KL-6 diffusion capacity (DLCO)
Time Frame: 3, 6 and12 months
|
Correlation of KL-6 and DLCO change at 3, 6 and 12 months
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3, 6 and12 months
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KL-6 symptoms
Time Frame: 3, 6 and12 months
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Correlation of KL-6 and symptom scores at 3, 6 and 12 months
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3, 6 and12 months
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KL-6 antifibrotics
Time Frame: 12 months
|
Change in KL-6 levels in response to antifibrotic therapy
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12 months
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KL-6 Gender Age and Physiology (GAP) stage
Time Frame: At baseline
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Differences in KL-6 levels between Gender Age Physiology (GAP) stage at baseline
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At baseline
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KL-6 CPI
Time Frame: At baseline
|
Correlation between KL-6 levels and Composite Physiology Index (CPI)
|
At baseline
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KL-6 CT pattern
Time Frame: At baseline
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Difference in KL-6 levels between patients with indeterminate, probable and definite usual interstitial pneumonia pattern (UIP) on HRCT
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At baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Conal Hayton, Manchester University NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ManchesterUNHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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