UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019826 |
|---|---|
| Receipt number | R000022868 |
| Scientific Title | Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2019/11/27 00:32:43 |
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Basic information
Public title
Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial
Acronym
Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial (PREDICT trial)
Scientific Title
Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial
Scientific Title:Acronym
Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial (PREDICT trial)
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to clarify the predictive factors to determine efficacy of anti-fibrotic drugs, and safety of the drugs in idiopathic pulmonary fibrosis including more severe cases than clinical trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Predictive factors of 5% or 10% decrease in forced vital capacity (FVC) of IPF one year after the start of anti-fibrotic drug.
Whether or not annual FVC decline before the start of anti-fibrotic drugs can predict the effectiveness of the drugs in IPF cases, FVC is measured before the start of the drugs.
Key secondary outcomes
1) Safety of anti-fibrotic drugs: adverse events between the two anti-fibrotic drugs. predictive factors of adverse events.
2) Prognosis and frequency of acute exacerbation within one year after the start of anti-fibrotic drugs.
3) Predictive factors to determine the change of annual FVC decline before and after the anti-fibrotic drugs.
4) Comparison of annual FVC decline between IPF with/without a pre-anti-fibrotic drug.
5) New serum parameters to determine effects of anti-fibrotic drugs.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Satisfy the diagnostic criteria of IPF.
2) Anti-fibrotic drugs, pirfenidone or nintedanib, are newly administered. Or Anti-fibrotic drug is changed to the other fibrotic drug.
3) Written informed consent.
Key exclusion criteria
1) Patients with contraindication of anti-fibrotic drugs.
Pirfenidone: hypersensitivity.
NIntedanib: hypersensitivity and pregnancy.
2) Patients improper to the trial according to the decision of a chief doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Inoue |
Organization
NHO Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180 Ngasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL
072-252-3021
inoue.yoshikazu.nt@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Arai |
Organization
NHO Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL
072-252-3021
Homepage URL
arai.toru.cp@mail.hosp.go.jp
Sponsor or person
Institute
NHO Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Review board of NHO Kinki-Chuo Chest Medical Center
Address
1180 Nagasone-Cho, Kita-Ku, Sakai Osaka, Japan
Tel
072-252-3021
agata.yuka.zd@mail.hosp.go.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
NHO近畿中央呼吸器センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 18 | 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 | 09 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Trial design: prospective cohort study
Subjects: see, inclusion criteria and exclusion criteria
Site of trial: NHO Kinki-Chuo Chest Medical Center. Not performed in the other institutions (Dec , 2015)
Observed parameters: Pulmonary function test (Forced vital capacity, diffusing capacity of carbon monoxide, etc), serum markers, 6-minute walk test, health-related quality of life (CAT score), occurrence of acute exacerbation, adverse events
Management information
Registered date
| 2015 | Year | 11 | Month | 17 | Day |
Last modified on
| 2019 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022868
| 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 |
