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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041380
Receipt No. 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

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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
Email 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
Email mtkatou@juntendo.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Juntendo University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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