UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039027 |
|---|---|
| Receipt number | R000044502 |
| Scientific Title | Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS) |
| Date of disclosure of the study information | 2019/12/27 |
| Last modified on | 2019/12/27 23:17:25 |
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Basic information
Public title
Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS)
Acronym
J-AVENGERS
Scientific Title
Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS)
Scientific Title:Acronym
J-AVENGERS
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of combination therapy of anti-fibrotic agents for IPF
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients whose annual decline of FVC was more than 10%
Key secondary outcomes
1. Comparison of decline of FVC before and after initiation of combination therapy
2. Proportion of incidence of acute exacerbation of IPF
3. Time to the acute exacerbation of IPF
4. Survival rate at 48 weeks
5. Proportion of incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
48 weeks of observational period, administration of nintedanib, 100mg or 150mg twice a day and pirfenidone, 200mg, 400mg, or 600mg 3 times a day
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)IPF diagnosed on IPF diagnosis guidelines published by American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association 2018
2)Patients who continue nintedanib
3)Patients whose FVC declined before initiation of combination therapy of anti-fibrotic agents
4)Patients with FVC > = 50%
5)Patients with DLCO > = 30%
6)Patients > = 40 year-old
7)Patients able to give informed consent
Key exclusion criteria
1)Patients with FEV1/FVC < 0.7
2)Patients who have treated with combination therapy of anti-fibrotic agents
3)Patients who require fibrinolysis, full-dose therapeutic anticoagulation, or high dose antiplatelet therapy
4)Patients who had acute exacerbation of IPF within 6 months
5)Patients who have uncontrolled complications (unstable angina, acute myocardial infarction, severe bronchial asthma, heart failure, bleeding tendency)
6)Patients who cannot perform pulmonary function test
7)Patients who are pregnant
8)Other patients who are judged to be inappropriate as a target by the doctor's judgment
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Inomata |
Organization
Japanese Red Cross Medical Canter
Division name
Department of Respiratory Medicine
Zip code
1508935
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
0334001311
inomata_minoru@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Inomata |
Organization
Japanese Red Cross Medical Canter
Division name
Department of Respiratory Medicine
Zip code
1508935
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
0334001311
Homepage URL
inomata_minoru@med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Medical Canter
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Medical Canter
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
Japanese Red Cross Medical Canter
Address
4-1-22 Hiroo Shibuya-ku Tokyo
Tel
0334001311
inomata_minoru@med.jrc.or.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 | 12 | Month | 27 | 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
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2019 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044502
