UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020392 |
|---|---|
| Receipt number | R000023549 |
| Scientific Title | Anti-fibrotic treatment in patients with idiopathic pulmonary fibrosis:A cohort study |
| Date of disclosure of the study information | 2015/12/29 |
| Last modified on | 2017/01/04 18:48:15 |
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Basic information
Public title
Anti-fibrotic treatment in patients with idiopathic pulmonary fibrosis:A cohort study
Acronym
Anti-fibrotic treatment in patients with IPF:A cohort study
Scientific Title
Anti-fibrotic treatment in patients with idiopathic pulmonary fibrosis:A cohort study
Scientific Title:Acronym
Anti-fibrotic treatment in patients with IPF:A cohort study
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The outcomes of patients with idiopathic pulmonary fibrosis who undergo treatment with anti fibrotic agents (pirfenidone and nintedanib) have not been well characterized. We sought to analyze the mortality of all-cause efficacy of antifibrotic agents among a cohort of patients with IPF.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was the association between anti fibrosis agents (pirfenidone and nintedanib) and survival in patients with IPF.
Key secondary outcomes
Other secondary outcomes included effect of pressure in the pulmonary circulation,response to inflammatory cytokine, miRNA, quality of life, and association between baseline patient characteristics and survival.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Satisfy the diagnostic criteria of IPF.
2) Anti fibroticc agents (pirfenidone or nintedanib) are administered.
3) Written informed consent.
Key exclusion criteria
without patients' consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | keishi Oda |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu city
TEL
093-691-7453
oda-keishi@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | keishi Oda |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu city
TEL
093-691-7453
Homepage URL
oda-keishi@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
none
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
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
産業医科大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Trial design: prospective cohort study
Study enrollment: December 2015 through November 2018. Patients who visit our hospital meet inclusion criteria are enrolled.
Observed parameters: Pulmonary function test, serum markers, 6-minute walk test, health-related quality of life, frequency of acute exacerbation, adverse events, pulmonary hypertension, inflammatory cytokine and blood gas analysis
Management information
Registered date
| 2015 | Year | 12 | Month | 29 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023549
| 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 |
