UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038192 |
|---|---|
| Receipt number | R000043516 |
| Scientific Title | Efficacy and Safety of Nintedanib in Japanese patients with early stage of idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2019/10/24 |
| Last modified on | 2023/04/06 13:18:42 |
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Basic information
Public title
Efficacy and Safety of Nintedanib in Japanese patients with early stage of idiopathic pulmonary fibrosis
Acronym
Kyushu-Okinawa early stage IPF study
Scientific Title
Efficacy and Safety of Nintedanib in Japanese patients with early stage of idiopathic pulmonary fibrosis
Scientific Title:Acronym
Efficacy and Safety of Nintedanib in Japanese patients with early stage of idiopathic pulmonary fibrosis
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis (IPF)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the safety, tolerability and efficacy of nintedanib in stage I/II of a Japanese disease severity staging classification system for IPF
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FVC at 156 week
Occurrence of adverse events in each SOC/PT
Key secondary outcomes
Secondary Endpoint(s) / Outcome:
1) Time to incidence of adverse events leading to nintedanib treatment discontinuation.
2) Time to incidence of adverse events leading to nintedanib dose reduction.
3) Incidence of adverse events leading to nintedanib treatment discontinuation.
4) Incidence of adverse events leading to nintedanib dose reduction.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of IPF according to the ATS/ERS/JRS/ALAT guidelines.
2) Stage I or II IPF based on the Japanese IPF disease severity classification.
Stage I:PaO2 at rest 80 torr and more
Stage II: PaO2 at rest 70-80 torr, and SpO2 90% and more during a 6-minute walk test
3) Patients who will start nintedanib for IPF.
4) Patients who are able and willing to provide written informed consent.
Key exclusion criteria
1)Patients who have initiated therapy with any antifibrotic agent for IPF.
2)Patients treated with corticosteroids (more than a prednisolone equivalent, 10 mg/day) or immunosuppressive agents.
3)Patients who are participating in any other interventional clinical trials.
4)Patients who are undergoing malignant tumor treatment.
5)Patients with a contraindication for nintedanib treatment.
Target sample size
215
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Mukae |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7273
hmukae@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriho |
| Middle name | |
| Last name | Sakamoto |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7273
Homepage URL
nsakamot@nagasaki-u.ac.jp
Sponsor or person
Institute
Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
| 2019 | Year | 10 | Month | 24 | 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
215
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter observational study, no specific treatment is mandated or with held from the patients. The choice of treatment must be according to regular medical practice and be at the discretion of the physician. In this study, the baseline and follow-up data will be collected at week 4, 13, 26, 39, 52, 82, 104, 130, 156 for the severity stage of I/II in IPF patients who have newly initiated the treatment with nintedanib. The patients will be followed up until the discontinuation of nintedanib, death, lung transplantation, or the end of study periods whichever comes first and will be censored if one of the events occurs.
To study the safety and the efficacy of nintedanib properly, the present study is conducted in the following sites; 1) a pulmonary physician specializing in interstitial lung diseases is present, 2) can assess the baseline characteristics of disease (date of assessment) including Japanese IIPs severity grade, PaO2 (at rest) and SpO2 (at 6-minutes walk test), 3) can register the appropriate subjects consecutively, 4)
can perform the necessary tests such as pulmonary function tests and laboratory tests. The present study focuses on the Japanese IIPs severity grade I/II. This will add the new data classified by pulmonary function and compared to the GAP score in patient with IPF treated by nintedanib.
Data collection will be performed by EDC system REDCap to ensure data reliability. In addition, data collected by REDCap will be robust to conclusion by conducting central monitoring.
Management information
Registered date
| 2019 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043516
