Idiopathic Pulmonary FibrosisLOCK-IPFNCT04268485
Longitudinal Changes in Serum KL-6 in IPF
An observational study of Idiopathic Pulmonary Fibrosis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Serum KL-6 level
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an MDT diagnosis of idiopathic pulmonary fibrosis attending routine follow-up care
Who may be able to join
- Age 18 or older
- Multi-disciplinary team (MDT) diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University hospitals NHS Foundation Trust
Manchester
Conal Hayton, conal.hayton@mft.nhs.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Serum KL-6 level
- Keywords
- KL-6, Krebs von den Lungen-6, Biomarker
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Medullary cystic kidney disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum KL-6 levelDiagnostic test
Serum blood biomarker which has been shown to be of interest in idiopathic pulmonary fibrosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Serum KL-6 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum KL-6 level
Change in serum KL-6 level between baseline and 12 months
Measured: 12 months
Secondary outcomes (8)
Serum KL-6 level at 3, 6 months
Change in serum KL-6 at 3 and 6 months compared to baseline
Measured: 3 and 6 months
KL-6 forced vital capacity (FVC) correlation
Correlation of KL-6 and FVC change at 3, 6 and 12 months
Measured: 3, 6 and12 months
KL-6 diffusion capacity (DLCO)
Correlation of KL-6 and DLCO change at 3, 6 and 12 months
Measured: 3, 6 and12 months
KL-6 symptoms
Correlation of KL-6 and symptom scores at 3, 6 and 12 months
Measured: 3, 6 and12 months
KL-6 antifibrotics
Change in KL-6 levels in response to antifibrotic therapy
Measured: 12 months
KL-6 Gender Age and Physiology (GAP) stage
Differences in KL-6 levels between Gender Age Physiology (GAP) stage at baseline
Measured: At baseline
KL-6 CPI
Correlation between KL-6 levels and Composite Physiology Index (CPI)
Measured: At baseline
KL-6 CT pattern
Difference in KL-6 levels between patients with indeterminate, probable and definite usual interstitial pneumonia pattern (UIP) on HRCT
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Feb 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Conal Hayton, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268485
- Sponsor's protocol ID
- ManchesterUNHS
- Acronym
- LOCK-IPF
- Status last verified
- Jun 2023
- First submitted
- 11 Feb 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Serum KL-6 Levels in Idiopathic Pulmonary Fibrosis (LOCK-IPF)
- ClinicalTrials.gov ID
- NCT04268485
- Acronym / sponsor ID
- LOCK-IPF / ManchesterUNHS
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- KL-6, Krebs von den Lungen-6, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPF patients | – | Diagnostic Test: Serum KL-6 levelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an MDT diagnosis of idiopathic pulmonary fibrosis attending routine follow-up care
Key inclusion criteria (2 listed)
- Age 18 or older
- Multi-disciplinary team (MDT) diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum KL-6 levelSerum blood biomarker which has been shown to be of interest in idiopathic pulmonary fibrosis | Diagnostic test | IPF patients |
Primary outcome
Serum KL-6 level
Time frame: 12 months
Change in serum KL-6 level between baseline and 12 months
8 secondary outcomes
Serum KL-6 level at 3, 6 months
Time frame: 3 and 6 months
KL-6 forced vital capacity (FVC) correlation
Time frame: 3, 6 and12 months
KL-6 diffusion capacity (DLCO)
Time frame: 3, 6 and12 months
KL-6 symptoms
Time frame: 3, 6 and12 months
KL-6 antifibrotics
Time frame: 12 months
KL-6 Gender Age and Physiology (GAP) stage
Time frame: At baseline
KL-6 CPI
Time frame: At baseline
KL-6 CT pattern
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conal Hayton principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conal Hayton, MBChB (+441612915388, conalhayton@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum KL-6 level (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023; AzTrials last refreshed its copy on 29 Oct 2026.