UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042254 |
|---|---|
| Receipt number | R000048233 |
| Scientific Title | Efficacy and safety of nintedanib for progressive fibrosing interstitial diseases in single center cohort study |
| Date of disclosure of the study information | 2020/10/31 |
| Last modified on | 2020/10/27 14:58:56 |
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Basic information
Public title
Efficacy and safety of nintedanib for progressive fibrosing interstitial diseases in single center cohort study
Acronym
Efficacy and safety of nintedanib for progressive fibrosing interstitial diseases
Scientific Title
Efficacy and safety of nintedanib for progressive fibrosing interstitial diseases in single center cohort study
Scientific Title:Acronym
Efficacy and safety of nintedanib for progressive fibrosing interstitial diseases
Region
| Japan |
Condition
Condition
progressive fibrosing interstitial lung diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
rate of acute exacerbation or death in 52 weeks
Key secondary outcomes
the rate of forced vital capacity decrease over 10%
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with PF-ILD other than IPF based on the 2018 ATS / ERS / JRS / ALAT international guidelines
2) Patients with fibrotic lesions of 10% or more on HRCT and progress of the condition within 24 months before enrollment despite standard treatment other than nintedanib
3) Nintedanib-free patients
4) Patients aged 18 years or older at the time of obtaining consent
5) Patients with written consent
Key exclusion criteria
1) Patients who have been treated with nintedanib
2) Patients requiring treatment with anticoagulants and high-dose antiplatelet drugs
3) Patients with a history of acute exacerbations within 6 months
4) Complications of poor control
5) Patients who cannot perform respiratory function test
6) Pregnant patients
7) Other patients who the doctor in charge deems inappropriate for safe administration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Kuse |
Organization
Japanese Red Cross Medical Center
Division name
Department of Respiratory Medicine
Zip code
150-8935
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
03-3400-1311
nao-k-u@nms.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Kuse |
Organization
Japanese Red Cross Medical Center
Division name
Department of Respiratory Medicine
Zip code
150-8935
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
03-3400-1311
Homepage URL
nao-k-u@nms.ac.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
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
Japanese Red Cross Medical Center
Address
4-1-22 Hiroo Shibuya-ku Tokyo
Tel
03-3400-1311
rinri@med.jrc.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1153
Org. issuing International ID_1
Japanese Red Cross Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本赤十字社医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 31 | 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 | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048233
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
