UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020682 |
|---|---|
| Receipt number | R000022819 |
| Scientific Title | The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2016/01/22 |
| Last modified on | 2023/07/28 11:09:56 |
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Basic information
Public title
The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis
Acronym
The comparison of antifibrotic agents in patients with idiopathic pulmonary fibrosis
Scientific Title
The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis
Scientific Title:Acronym
The comparison of antifibrotic agents in patients with idiopathic pulmonary fibrosis
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare the efficacy and safety of pirfenidone and nintedanib to identify the background and characteristics of the responders to each drug and discover appropriate use of these antifibrotic agents based on each individual patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the change in vital capacity from baseline to months 12
Key secondary outcomes
dyspnea, KL-6, SP-D, %DLCO, changes in the lowest peripheral oxygen saturation during the 6-minute walk test, arterial blood gas, the reduction of ground-glass and reticular opacities, echocardiogram, bronchoalveolar lavage, first occurence of acute exacerbation, the development of lung cancer, survival at 12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pirfenidone 12 months 200-600mg t.i.d or b.i.d
Interventions/Control_2
nintedanib 12 months 100-150mg b.i.d
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
Eligible patients are diagnosed as having idiopathic pulmonary fibrosis using the official American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) statement.
Key exclusion criteria
the patients with coexisting lung cancer, acute exacerbation of idiopathic pulmonary fibrosis, severe cardiac or hepatic diseases, pulmonary arterial hypertension, sarcoidosis and respiratory infection, the patients who cannot perform pulmonary function test, pregnant women, use of prednisone greater than 20mg/day and immunosuppressives during the preceding 3 months, the patients who participated in other clinical trials in the last 3 months, the patients who are judged inappropriate for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Miura |
Organization
National Hospital Organization Ibarakihigashi National Hospital
The center of Chest Diseases and Severe Motor&Intellectual Disabilities
Division name
Department of Respiratory medicine
Zip code
3191113
Address
825, Terunuma, Tokai-mura, Naka-gun, Ibaraki, Japan 3191113
TEL
029-282-1151
s7081@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Miura |
Organization
National Hospital Organization Ibarakihigashi National Hospital
Division name
Department of Respiratory medicine
Zip code
3191113
Address
825, Terunuma, Tokai-mura, Naka-gun, Ibaraki, Japan 3191113
TEL
029-282-1151
Homepage URL
s7081@nms.ac.jp
Sponsor or person
Institute
National Hospital Organization Ibarakihigashi National Hospital
The center of Chest Diseases and Severe Motor&Intellectual Disabilities
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Ibarakihigashi National Hospital
The center of Chest Diseases and Severe Motor&Intellectual Disabilities
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Ibarakihigashi National Hospital The center of Chest Diseases and Severe Motor&Intellectual Disabilities
Address
825, Terunuma, Tokai-mura, Naka-gun, Ibaraki, Japan 3191113
Tel
029-282-1151
s7081@nms.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
| 2016 | Year | 01 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022819
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| Registered date | File name |
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