UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059748 |
|---|---|
| Receipt number | R000068322 |
| Scientific Title | Clinically Significant Outcomes, Disease Burden, Treatment and Management in Fibrosing Interstitial Lung Disease in Japan- A National Database Study |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/12 13:33:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinically Significant Outcomes, Disease Burden, Treatment and Management in Fibrosing Interstitial Lung Disease in Japan- A National Database Study
Acronym
Fibrosing ILD-related clinically significant outcomes in Japan - A National Database Study
Scientific Title
Clinically Significant Outcomes, Disease Burden, Treatment and Management in Fibrosing Interstitial Lung Disease in Japan- A National Database Study
Scientific Title:Acronym
Fibrosing ILD-related clinically significant outcomes in Japan - A National Database Study
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 investigate the cumulative incidences of clinically significant outcomes such as mortality (including lung transplantation), all cause hospitalisation, respiratory hospitalisation, and acute exacerbation in patients with fibrosing ILDs 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
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the cumulative incidences of clinically significant outcomes such as mortality (including lung transplantation), all cause hospitalisation, respiratory hospitalisation, and acute exacerbation in patients with fibrosing ILDs in Japan.
Key secondary outcomes
To describe baseline demographic and clinical characteristics in patients with fibrosing ILDs in Japan.
To describe the distribution of PPF progression proxies met in patients with progression to PPF.
To describe healthcare resource utilisation (HCRU) and medical cost in patients with fibrosing ILDs in Japan.
To describe clinical practice on treatment and management in patients with fibrosing ILDs 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 diagnosed with at least 2 fibrosing ILD codes in different months during the patient identification period
Patients aged 20 years or older on the index date
Patients for whom data for the 12 months prior to the index date can be extracted as baseline data
Key exclusion criteria
None
Target sample size
200000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ito |
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
03-6417-2780
tomohiro.ito@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ito |
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
03-6417-2780
Homepage URL
tomohiro.ito@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
1305-0058
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 | 02 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | 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 | 12 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068322
