UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062524 |
|---|---|
| Receipt number | R000070885 |
| Scientific Title | Antifibrotic therapy for Interstitial Lung disease: a Prospective Study in Koshinetsu region |
| Date of disclosure of the study information | 2026/08/15 |
| Last modified on | 2026/08/09 10:12:20 |
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Basic information
Public title
Antifibrotic therapy for Interstitial Lung disease: a Prospective Study in Koshinetsu region
Acronym
ALPS Study
Scientific Title
Antifibrotic therapy for Interstitial Lung disease: a Prospective Study in Koshinetsu region
Scientific Title:Acronym
ALPS Study
Region
| Japan |
Condition
Condition
Interstitialu lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the prescription proportions of various antifibrotic therapies and patient clinical characteristics in a multicenter real-world database of patients with interstitial lung disease (ILD). Furthermore, this study aims to clarify the differences in treatment status between elderly and younger patients, and to evaluate the impact of baseline nutritional status, skeletal muscle mass, and longitudinal changes in nutritional indices on the long-term prognosis and clinical events of ILD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The proportion of each antifibrotic drug prescription, as well as the rates and specific reasons for drug switching or combination therapy (add-on) at baseline.
Key secondary outcomes
1. Patient clinical characteristics at the time of registration, including age, sex, clinical diagnosis.
2. Overall survival (OS) and progression-free survival (PFS) during the 36-month follow-up period.
3. Longitudinal changes in respiratory function (FVC, FEV1) and patient-reported symptoms (mMRC, CAT) at 6 months, 1, 2, and 3 years.
4. Safety profiles of antifibrotic drugs (incidence and severity of adverse events graded by CTCAE, and their impact on dose reduction or interruption), including a comparative analysis between elderly and younger cohorts.
5. Evaluation of the impact of baseline nutritional status, skeletal muscle mass, and longitudinal weight loss rates on disease progression (FVC decline >5%, acute exacerbation, unplanned emergency hospitalization, and mortality) using Cox proportional hazards models.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), at the participating institutions.
2. Patients who are scheduled to initiate or have already initiated a new or additional antifibrotic drug (e.g., nintedanib, pirfenidone, nerandomilast).
3. Patients aged 20 years or older at the time of registration.
Key exclusion criteria
1. Patients who decline to participate in the study via the opt-out public notification.
2. Patients otherwise judged inappropriate for enrollment by the principal investigator or sub-investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Komatsu |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263-37-2631
mskomatsu@shinhu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Komatsu |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
3-3-1, Asahi, Matsumoto, Nagano
TEL
0263-37-2631
Homepage URL
mskomatsu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
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
Shinshu University School of Medicine
Address
3-1-1, Asahi, Matsumoto city, Nagano
Tel
0263-37-2631
mskomatsu@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
長野県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 08 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070885
