UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone
Title of the study (Brief title)	Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone
Region	Japan

Condition
Condition	idiopathic pulmonary fibrosis
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of a nintedanib plus pirfenidone and nintedanib alone following a clinically meaningful decline in forced vital capacity in patients with IPF who experienced atients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The ratio of patients who experienced >5% absolute decline in %FVC or death during the first 6-months
Key secondary outcomes	1) The ratio of patients who experienced >10% absolute decline in %FVC or death during the first 6-months 2) Decline of FVC at 1,3,6,9,12 months 3) The occurence rate of acute excerbation 4) Change in %FVC and %DLco 5) 6 minutes walk test 6) Serum biomarker 7) HRCT findings 8) Toxicity 9) Progression free survival 10) Survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Nintedanib+pirfenidone group; Nintedanib 150mg twice daily Pirfenidone 600-1800mg/day
Interventions/Control_2	Nintedanib group; Nintedanib 150mg twice daily
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) Idiopathic pulmonary fibrosis 2) >= 40 years old 3) Pirfenidone (600-1800mg/day) was administered for more than 3 months 4) patients who experience a >=5% decline in forced vital capacity within the recent 6 months 5) Adequate organ functions 6) Survival >= 6 months is expected 7) Written informed consent
Key exclusion criteria	1) AST/ALT/T-bil >= reference value * 2.5 2) The patients who has already received corticosteroid (<=15mg/day), immuno-supressant, NAC, pulmonary vasodilators, and other treatment for IPF 3) Active infection 4) Malignant tumor 5) Other severe complication 6) pregnant or lactating woman 7) severe drug allergy 8) It is determined that it is not suited
Target sample size	60

Research contact person
Name of lead principal investigator	Takashi Ogura
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Respiratory Medicine
Address	Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
TEL	0457019581
Email	ogura@kanagawa-junko.jp

Public contact
Name of contact person	Satoshi Ikeda
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Respiratory Medicine
Address	Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
TEL	0457019581
Homepage URL	http://junko.kanagawa-pho.jp/
Email	isatoshi0112@gmail.com

Sponsor
Institute	Kanagawa Cardiovascular and Respiratory Center
Institute
Department

Funding Source
Organization	No funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	神奈川県立循環器呼吸器病センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 27 Day
Anticipated trial start date	2015 Year 10 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 21 Day
Last modified on	2018 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022471