UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060770 |
|---|---|
| Receipt number | R000069531 |
| Scientific Title | The Utility of the FIB-4 Index in Patients with Progressive Fibrosing Interstitial Lung Diseases: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/16 10:53:59 |
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Basic information
Public title
The Utility of the FIB-4 Index in Patients with Progressive Fibrosing Interstitial Lung Diseases: A Retrospective Cohort Study
Acronym
The Utility of the FIB-4 Index in Patients with Progressive Fibrosing Interstitial Lung Diseases: A Retrospective Cohort Study
Scientific Title
The Utility of the FIB-4 Index in Patients with Progressive Fibrosing Interstitial Lung Diseases: A Retrospective Cohort Study
Scientific Title:Acronym
The Utility of the FIB-4 Index in Patients with PF-ILD
Region
| Japan |
Condition
Condition
Progressive fibrosing interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of the FIB-4 Index as a prognostic factor for progressive fibrosing interstitial lung disease
Basic objectives2
Others
Basic objectives -Others
To investigate the utility of the NFS score and APRI score can serve as prognostic factors for interstitial lung disease with progressive fibrosis, in addition to the FIB-4 Index.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
delta FVC from baseline (ml/year) (liner mixed model)
Key secondary outcomes
Time to first acute exacerbation or death
Correlation between KL-6 and FIB-4 index (Spearman)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients and study period: We included patients with progressive fibrosing interstitial lung disease (PF-ILD) who had received nintedanib at Yamanashi Red Cross Hospital between September 1, 2015 and February 28, 2026.
Baseline laboratory data: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count were required to be measured within 30 days before or after nintedanib initiation; when multiple measurements were available within this window, the value closest to the initiation date was used.
Follow-up availability: Patients were required to have ascertainable follow-up after nintedanib initiation, with either the date of death or the date of last confirmed clinical contact documented.
Consent: Informed consent was obtained using an opt-out procedure.
Key exclusion criteria
Baseline laboratory data: AST, ALT, and platelet count were not measured within 30 days of nintedanib initiation. AST, ALT, and platelet count obtained within 30 days of nintedanib initiation were judged by the treating clinician to reflect an acute illness (i.e., not representative of baseline status).
Drugs: Use of any antifibrotic agent within the 90 days prior to cohort entry.
Consent: Informed consent could not be obtained via the opt-out procedure.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Yamanashi Red Cross Hospital
Division name
Department of Medicine, Division of Respiratory Medicine
Zip code
401-0301
Address
6663-1, Funatsu, Fujikawaguchiko-machi, Yamanashi
TEL
0555-72-2222
yosukefukuda.showa@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Yamanashi Red Cross Hospital
Division name
Department of Medicine, Division of Respiratory Medicine
Zip code
401-0301
Address
6663-1, Funatsu, Fujikawaguchiko-machi, Yamanashi
TEL
0555-72-2222
Homepage URL
yosukefukuda.showa@gmail.com
Sponsor or person
Institute
Yamanashi Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamanashi Red Cross Hospital
Address
6663-1, Funatsu, Fujikawaguchiko-machi, Yamanashi
Tel
0555-72-2222
yrckokyuki@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069531
