UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041380 |
|---|---|
| Receipt number | R000047242 |
| Scientific Title | The safety and efficacy of nintedanib for patients with progressive fibrosing interstitial lung disease in a real world setting-a prospective observational study |
| Date of disclosure of the study information | 2020/08/11 |
| Last modified on | 2020/08/10 20:48:35 |
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Basic information
Public title
The safety and efficacy of nintedanib for patients with progressive fibrosing interstitial lung disease in a real world setting-a prospective observational study
Acronym
Nintedanib for PF-ILD in a real world setting
Scientific Title
The safety and efficacy of nintedanib for patients with progressive fibrosing interstitial lung disease in a real world setting-a prospective observational study
Scientific Title:Acronym
Nintedanib for PF-ILD in a real world setting
Region
| Japan |
Condition
Condition
Progressive fibrosing interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety and efficacy of nintedanib for patients with PF-ILD in a real world setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mortality rate by acute exacerbation of ILD
Key secondary outcomes
(1) FVC decline at 52 weeks from the initiation of nintedanib
(2) Survival rate at 52 weeks
(3) Incidence of adverse effects (>Grade 3)
(4) PFS at 52 weeks
(5) Change of FVC
(6) Change of symptoms (dyspnea and cough) at 52 weeks
(7) Change of DLCO, 6MWT, ABG, Aa-DO2, serum markers
(8) Change of HRCT findings at 52 weeks
(9) Change of PAP
(10) Change of CTR-related findings and symptoms at 52 weeks
(11) Persistency rate of treatment with nintedanib at 52 weeks
(12) Survival time
(13) Time to first acute exacerbation
(14) Difference in the incidence and the fatality rate of acute exacerbation among primary disease
(15) Association between disease phenotype and effectiveness of nintedanib
(16) Association between pathological findings and effectiveness of nintedanib
(17) Association between biomarker and effectiveness of nintedanib
(18) FVC decline, survival rate, nintedanib continuation rate at 104, 156, 208, 260 weeks
(19) Incidence of lung cancer development
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) A Patient who was clinically diagnosed with ILD
(2) A Patient who was clinically diagnosed with PF-ILD
(3) A Patient who will receive nintedanib within 1 month
(4) Aged >=20 years and <85 years
(5) A patient who agree that they participate by written consent
Key exclusion criteria
(1) Difficulty obtaining patients' consent
(2) Severe heart disease
(3) AST >=2*ULN, ALT >=2*ULN, or T-bil >=2*ULN
(4) Pregnancy
(5) Coexistence with pulmonary arterial hypertension, bronchial asthma, Malignant tumor, sarcoidosis, bronchiectasis, respiratory infection
(6) A patient who already receive nintedanib or other anti-fibrotic agents
(7) A patient with risk of fatal bleeding
(8) Past history of thrombosis less than 3 months
(9) A patient who started clinical trials less than 3 months
(10) A patient improper to this clinical trial according to the decision of a principal investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motoyasu |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku
TEL
0338133111
mtkatou@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Motoyasu |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University Hospital
Division name
Department of Respiratory Medicine
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku
TEL
03-3813-3111
Homepage URL
mtkatou@juntendo.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Juntendo University Hospital
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
Juntendo Clinical Research and Trial Center
Address
3-1-3, Hongo, Bunkyo-ku
Tel
0338133111
kenkyu5858@juntendo.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
| 2020 | Year | 08 | Month | 11 | 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
| 2020 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observation study
Management information
Registered date
| 2020 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047242
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| Registered date | File name |
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