UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042946 |
|---|---|
| Receipt number | R000048981 |
| Scientific Title | Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial) |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2024/01/11 12:01:07 |
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Basic information
Public title
Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)
Acronym
Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)
Scientific Title
Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)
Scientific Title:Acronym
Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)
Region
| Japan |
Condition
Condition
Idiopathic pleuroparenchymal fibroelastosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of nintedanib in patients with idiopathic pleuroparenchymal fibroelastosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
%FVC decline rate during 26-week treatment of nintedanib versus the rate of baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
150 mg bid nintedanib over 26 weeks
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
Provided written informed consent
Confirmed definite idiopathic PPFE or probable idiopathic PPFE before the registration
Have more than 50% of %FVC
Have more than relative 5% decline of %FVC within 1 year of visit 1
etc.
Key exclusion criteria
Have a history of treatment either with pirfenidone or nintedanib
NAC, prednisone > 15 mg/day or equivalent, azathioprine, cyclosporine or cyclophosphamide received within 8 weeks of visit 1
Have airway obstruction
Have lung cancer
Have pulmonary hypertension
Developed acute exacerbation within 3 months of visit 1
etc.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Nishioka |
Organization
Graduate School of Biomedical Sciences
Tokushima University
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima, Japan
TEL
088-633-7127
yasuhiko@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kojin |
| Middle name | |
| Last name | Murakami |
Organization
Graduate School of Biomedical Sciences Tokushima University
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima, Japan
TEL
088-633-7127
Homepage URL
murakami.kojin@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Rheumatology
Graduate School of Biomedical Sciences
Tokushima University
Institute
Department
Personal name
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
Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The trial is on going. 11/Jan/2024
Management information
Registered date
| 2021 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048981
