UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058009 |
|---|---|
| Receipt number | R000066310 |
| Scientific Title | Oral Antifibrotic Agents in Pulmonary Fibrosis |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/11/06 09:11:07 |
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Basic information
Public title
Oral Antifibrotic Agents in Pulmonary Fibrosis
Acronym
Oral Antifibrotic Agents in Pulmonary Fibrosis
Scientific Title
Oral Antifibrotic Agents in Pulmonary Fibrosis
Scientific Title:Acronym
Oral Antifibrotic Agents in Pulmonary Fibrosis
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Pulmonary Fibrosis (IPF/PPF)
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study employed a network meta-analysis of randomized controlled trials to evaluate the efficacy and safety of oral antifibrotic agents in patients with pulmonary fibrosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FVC
Key secondary outcomes
AEs
Base
Study type
Others,meta-analysis etc
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
1. RCT
2. Diagnosis with Pulmonary Fibrosis
3. Oral Antifibrotic Agents
Key exclusion criteria
1. Subgroup analysis without adding new information
2. Data not available
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Tagami |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1 Tomioka Higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-701-9581
abroadhp@gmail.com
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Tagami |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine,
Zip code
236-0051
Address
6-16-1 Tomioka Higashi, Kanazawa-ku, Yokohama, Kanagawa 236-0051, Japan
TEL
045-701-9581
Homepage URL
abroadhp@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cardiovascular and Respiratory Center
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
Kanagawa Cardiovascular and Respiratory Center IRB
Address
6-16-1 Tomioka Higashi, Kanazawa-ku, Yokohama, Kanagawa 236-0051, Japan
Tel
045-701-9581
abroadhp@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
| 2025 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.69854/jcq.2025.0021
Number of participants that the trial has enrolled
4206
Results
Combination therapies involving nerandomilast showed limited additional benefit, highlighting the need for personalized treatment strategies and long-term data.
Results date posted
| 2025 | Year | 11 | Month | 06 | Day |
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
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No additional information
Management information
Registered date
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066310
