UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021036 |
|---|---|
| Receipt number | R000024199 |
| Scientific Title | Effects of nintedanib in idiopathic pulmonary fibrosis - analysis on long term prognosis and predictive factors - |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2017/08/18 18:07:48 |
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Basic information
Public title
Effects of nintedanib in idiopathic pulmonary fibrosis - analysis on long term prognosis and predictive factors -
Acronym
Effects of nintedanib in idiopathic pulmonary fibrosis
Scientific Title
Effects of nintedanib in idiopathic pulmonary fibrosis - analysis on long term prognosis and predictive factors -
Scientific Title:Acronym
Effects of nintedanib in idiopathic pulmonary fibrosis
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nintedanib is a multiple tyrosine kinase inhibitor and has been demonstrated to be effective in idiopathic pulmonary fibrosis (IPF) in respect of inhibiting the deterioration of pulmonary function. However, its effect on long term prognosis and predictive factors are still to be determined. The aim of the present study is to clarify the long term prognosis and predictive factors by means of prospectively following the cases of IPF treated with nintedanib.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival, cumulative incidence of acute exacerbation
Key secondary outcomes
Overall survival in individual pre-assumed predictive factors, cumulative incidence of acute exacerbation in individual pre-assumed predictive factors, adverse effects
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Cases that have been diagnosed as definite IPF, defined by the international guideline (Raghu G. et al, Am J Respir Crit Care Med 2011;183:788-824).
2. No prior treatment (cortico-steroids, immunosuppressive therapy, pirfenidone, nintedanib).
Key exclusion criteria
1. Cases with severe liver, renal or metabolic dysfunction.
2. Complicated by malignancy.
3. Any other cases that the attending physician considers to be inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oyamada |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1 Higashigaoka Meguro-ku Tokyo Japan
TEL
03-3411-0111
yoyamada@ntmc-hosp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oyamada |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1 Higashigaoka Meguro-ku Tokyo Japan
TEL
03-3411-0111
Homepage URL
yoyamada@ntmc-hosp.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Tokyo Medical Center, Department of Respiratory Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Chugai Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co., Ltd.
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構東京医療センター（東京都）、川崎市立川崎病院（神奈川県）、東京都済生会中央病院（東京都）、佐野厚生総合病院（栃木県）、日野市立病院（東京都）、日本鋼管病院（神奈川県）、東海大学八王子病院（東京都）、立川共済病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 16 | 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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: cohort study
Study enrollment: February 16th 2016 through March 31st 2019
Measured parameters:
Blood samples (KL-6, cytokines, arterial blood gases), pulmonary function tests (spirometry, DLco), 6 minute walk test etc.
Management information
Registered date
| 2016 | Year | 02 | Month | 15 | Day |
Last modified on
| 2017 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024199
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/08/18 | 研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/08/18 | 症例登録シート.doc |
| Research case data | |
|---|---|
| Registered date | File name |
