UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059774 |
|---|---|
| Receipt number | R000068326 |
| Scientific Title | Utilization and cost estimation in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in Japan - A National Database Study |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/12 15:24:18 |
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Basic information
Public title
Utilization and cost estimation in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in Japan - A National Database Study
Acronym
Utilization and cost estimation in patients with IPF and PPF, Japan (NDB)
Scientific Title
Utilization and cost estimation in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in Japan - A National Database Study
Scientific Title:Acronym
Utilization and cost estimation in patients with IPF and PPF, Japan (NDB)
Region
| Japan |
Condition
Condition
IPF, PPF, and non-progressive ILD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the treatment patterns of antifibrotic drugs in patients with IPF and PPF in Japan
Basic objectives2
Others
Basic objectives -Others
Descriptive and Outcome Research of Retrospective Observational Study by Secondary Use of Public Health Care Database (NDB)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To describe the treatment patterns of antifibrotic drugs in patients with IPF and PPF in Japan
Key secondary outcomes
To clarify direct medical costs in patients with IPF and PPF receiving antifibrotic drugs in Japan
To describe the most frequent medical procedures in patients with IPF and PPF receiving antifibrotic drugs in Japan
To describe the Healthcare Resource Utilization (HCRU) during the period of antifibrotic drug treatment and the post-treatment period in patients with IPF and PPF receiving antifibrotic drugs in Japan
To estimate attributable costs associated with the occurrence of specific events (home oxygen therapy [HOT], acute exacerbation) in patients with IPF and PPF receiving antifibrotic drugs in Japan
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received first administration of antifibrotic drugs after August 31, 2015
Patients diagnosed with fibrosing ILD on or before the month of the index date
Patients aged 20 years or older on the index date
Having record at least 30 days from the date of first administration of antifibrotic drugs
Patients having record at least 12 months prior to the index date
Key exclusion criteria
Patients who have lung transplantation before the index date
Target sample size
160000
Research contact person
Name of lead principal investigator
| 1st name | Tatsuki |
| Middle name | |
| Last name | Ishizuka |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Division
Zip code
141-6017
Address
ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo,
TEL
03-6417-2794
tatsuki.ishizuka@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Tatsuki |
| Middle name | |
| Last name | Ishizuka |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Division
Zip code
141-6017
Address
ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo,
TEL
03-6417-2794
Homepage URL
tatsuki.ishizuka@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SOUKEN Co., Ltd
Address
6F, Daiwa A Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1555
y_huzita@mail.souken-r.com
Secondary IDs
Secondary IDs
YES
Study ID_1
1305-0061
Org. issuing International ID_1
Boehringer Ingelheim International GmbH
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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
| 2025 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068326
