UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062969 |
|---|---|
| Receipt number | R000072066 |
| Scientific Title | A Prospective Observational Study on Clinical Outcomes Following the Introduction of Nelandomirast in Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) |
| Date of disclosure of the study information | 2026/09/17 |
| Last modified on | 2026/09/17 19:26:13 |
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Basic information
Public title
A Prospective Observational Study on Clinical Outcomes Following the Introduction of Nelandomirast in
Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)
Acronym
A Prospective Observational Study on Clinical Outcomes Following the Introduction of Nelandomirast in
Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)
Scientific Title
A Prospective Observational Study on Clinical Outcomes Following the Introduction of Nelandomirast in
Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)
Scientific Title:Acronym
A Prospective Observational Study on Clinical Outcomes Following the Introduction of Nelandomirast in
Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)
Region
| Japan |
Condition
Condition
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF)
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes over time in lung function and biomarkers following the initiation of nelandomirast in Japanese patients with IPF/PPF
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in %FVC Over 52 Weeks
Key secondary outcomes
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. Men and women aged 20 years or older (at the time of obtaining consent)
2. Patients who meet the diagnostic criteria for IPF (2022 ATS/ERS/JRS/ALAT guidelines) or PPF (2022 ATS/ERS/JRS/ALAT guidelines)
3. Patients who can obtain written consent
Key exclusion criteria
1. Patients with severe hepatic impairment (Child-Pugh Class C)
2. Patients with a history of severe hypersensitivity to PDE4 inhibitors
3. Patients whom the attending physician deems unsuitable for enrollment in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Arai |
Organization
National Hospital Organization Ibarakihigashi National Hospital
Division name
Department of Respiratory Medicine
Zip code
319-1113
Address
825,Terunuma, Tokai-mura, Nakagun,Ibaraki,Japan
TEL
0292821151
snki7788@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Arai |
Organization
National Hospital Organization Ibarakihigashi National Hospital
Division name
Department of Respiratory Medicine
Zip code
319-1113
Address
825,Terunuma, Tokai-mura, Nakagun,Ibaraki,Japan
TEL
0292821151
Homepage URL
snki7788@gmail.com
Sponsor or person
Institute
National Hospital Organization Ibarakihigashi National Hospital
Institute
Department
Personal name
Naoki Arai
Funding Source
Organization
None
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
Institutional Review Board of Ibarakihigashi National Hospital
Address
825,Terunuma, Tokai-mura, Nakagun,Ibaraki,Japan
Tel
0292821151
snki7788@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
| 2026 | Year | 09 | Month | 17 | 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
| 2026 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center prospective observational cohort study. Patients initiated with Nelandmilast for IPF and PPF will be prospectively enrolled, and disease trajectory, treatment continuation rate, adverse event incidence, and overall survival will be evaluated over 52 weeks. The observation period will be 2 years.
Management information
Registered date
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072066
