UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062558 |
|---|---|
| Receipt number | R000071610 |
| Scientific Title | Real-World Experience and Clinical Course of Antifibrotic Therapy: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/08/15 |
| Last modified on | 2026/08/15 11:17:41 |
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Basic information
Public title
Real-World Experience and Clinical Course of Antifibrotic Therapy: A Prospective Observational Study
Acronym
Real-World Experience and Clinical Course of Antifibrotic Therapy: A Prospective Observational Study
Scientific Title
Real-World Experience and Clinical Course of Antifibrotic Therapy: A Prospective Observational Study
Scientific Title:Acronym
A Prospective Observational Study of Antifibrotic Therapy
Region
| Japan |
Condition
Condition
fibrotic interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the clinical course of patients with fibrotic interstitial lung disease initiating nerandomilast in a multicenter setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To prospectively investigate disease progression (defined as meeting at least two of the following criteria: decline in lung function, worsening of symptoms, or worsening of imaging findings) after initiating the antifibrotic agent nerandomilast in a multicenter setting.
Key secondary outcomes
1) Overall survival after the initiation of the antifibrotic agent
(2) Change in percent predicted forced vital capacity (%FVC) after the initiation of the antifibrotic agent
(3) Imaging findings (percentage of fibrotic lesions relative to total lung volume on chest CT) after the initiation of the antifibrotic agent
(4) Incidence of acute exacerbation
(5) Incidence of lung cancer
(6) Rate of drug modification and treatment continuation due to adverse events
(7) Cumulative survival rate
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
1. Patients aged 20 years or older
2. Patients who have provided written informed consent for participation in this study by signing the consent form
Key exclusion criteria
1. Patients with progressive or active malignant tumors
2. Women who are pregnant or who may be pregnant
3. Women who are breastfeeding
4. Patients deemed unsuitable for participation by a sub-investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Fujisawa |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
4313192
Address
1-20-1, Handatyama, Chuo-ku, Hamamatsu
TEL
0534352263
yuzosuzu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuzo |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
4313192
Address
1-20-1, Handatyama, Chuo-ku, Hamamatsu
TEL
0534352263
Homepage URL
yuzosuzu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicne
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicne
Address
1-20-1, Handayama, Chuo-ku, Hamamatsu
Tel
0534352263
yuzosuzu@hama-med.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
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 | 08 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2031 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not Applicapble
Management information
Registered date
| 2026 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071610
