UMIN-CTR Clinical Trial

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
Email	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
Email	arai.toru.cp@mail.hosp.go.jp

Sponsor
Institute	NHO Kinki-Chuo Chest Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022868