UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038148 |
|---|---|
| Receipt number | R000042556 |
| Scientific Title | The Prospective Observational Study for Realistically Concomitant Use of Corticosteroid in Idiopathic Pulmonary Fibrosis during Treatment with Anti-fibrotic Agents |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/09/30 21:21:42 |
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Basic information
Public title
The Prospective Observational Study for Realistically Concomitant Use of Corticosteroid in Idiopathic Pulmonary Fibrosis during Treatment with Anti-fibrotic Agents
Acronym
Steroid Treatment for IPF Patients during Anti-fibrotic Agents Therapy
Scientific Title
The Prospective Observational Study for Realistically Concomitant Use of Corticosteroid in Idiopathic Pulmonary Fibrosis during Treatment with Anti-fibrotic Agents
Scientific Title:Acronym
Steroid Treatment for IPF Patients during Anti-fibrotic Agents Therapy
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Researching the safety and efficacy of the combination treatment with both anti-fibrotic agents and corticosteroid for idiopathic pulmonary fibrosis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate after 52 weeks
Key secondary outcomes
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 IPF
(2) Having UIP or probable UIP pattern on HRCT based on the ATS/ERS/JRS/ALAT guideline in 2018
(3) FVC >=50% of predicted, DLCO >=30% of predicted, and FEV1 >=0.7.
(4) Aged >=20 years and <=85 years
(5) All grade of severity (GAP index and Japanese severity of IIPs)
(6) A Patient who will receive nintedanib or pirfenidone or patients who was initiated to treatment with nintedanib or pirfenidone within 1 month
(7) Patients who agree that they participate by written consent
(8) The rate of lymphocyte is more than 30%
(9) One or more the serum auto-immune-related markers, including RF, ANA, anti-DNA, anti-ARS, anti-scl-70, SS-A, SS-B, or ANCA) is positive
Key exclusion criteria
(1) Severe heart disease
(2) AST >=1.5*ULN or ALT >=1.5*ULN,
(3) T-bil >=1.5*ULN
(4) Cr >=1.5*ULN
(5) A patient who had ever received anti-cancer agents or radiation therapy
(6) Pregnancy
(7) A patient who can not receive pulmonary function test
(8) A patient who already receive immunosuppressant, including azatiopurinn, cyclosporine, cyclophosphamide, methotrexate, tacrolimus)
(9) Coexistence with pulmonary arterial hypertension, bronchial asthma, Malignant tumor, sarcoidosis, bronchiectasis, respiratory infection
(10) A patient with risk of fatal bleeding
(11) Past history of thrombosis
(12) Having HBV antigen and HVB-DNA
(13) A patient who started clinical trials less than 3 months
(14) A patient improper to this clinical trial according to the decision of a principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Azuma |
Organization
Nipponn Medical University Musashi Kosugi Hospital
Division name
Department of Pulmonary Medicine and Oncology
Zip code
211-8533
Address
1-396 Kosigi-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL
044-733-5181
a-azuma@nms.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
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
mtkatou@juntendo.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Juntendo University Hospital
Institute
Department
Personal name
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, Tokyo
Tel
03-3813-3111
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
| 2019 | Year | 10 | Month | 01 | 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 | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2019 | Year | 09 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042556
