UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019436 |
|---|---|
| Receipt number | R000022471 |
| Scientific 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 |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2018/10/27 10:34:43 |
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Basic information
Public 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
Acronym
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
Scientific 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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takashi Ogura |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
Address
Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
TEL
0457019581
ogura@kanagawa-junko.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ikeda |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
Address
Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
TEL
0457019581
Homepage URL
http://junko.kanagawa-pho.jp/
isatoshi0112@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 27 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022471
