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

Recruiting

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

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with an MDT diagnosis of idiopathic pulmonary fibrosis attending routine follow-up care

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
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
KL-6 diffusion capacity (DLCO)
Time Frame: 3, 6 and12 months
Correlation of KL-6 and DLCO change at 3, 6 and 12 months
3, 6 and12 months
KL-6 symptoms
Time Frame: 3, 6 and12 months
Correlation of KL-6 and symptom scores at 3, 6 and 12 months
3, 6 and12 months
KL-6 antifibrotics
Time Frame: 12 months
Change in KL-6 levels in response to antifibrotic therapy
12 months
KL-6 Gender Age and Physiology (GAP) stage
Time Frame: At baseline
Differences in KL-6 levels between Gender Age Physiology (GAP) stage at baseline
At baseline
KL-6 CPI
Time Frame: At baseline
Correlation between KL-6 levels and Composite Physiology Index (CPI)
At baseline
KL-6 CT pattern
Time Frame: At baseline
Difference in KL-6 levels between patients with indeterminate, probable and definite usual interstitial pneumonia pattern (UIP) on HRCT
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Conal Hayton, Manchester University NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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