UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020722 |
|---|---|
| Receipt number | R000023054 |
| Scientific Title | Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2016/01/25 05:19:30 |
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Basic information
Public title
Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis
Acronym
The CT study with Nintedanib
Scientific Title
Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis
Scientific Title:Acronym
The CT study with Nintedanib
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Medicine in general | Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the change in fibrosis score of computed tomography over 52-week after treatment with Nintedanib
Key secondary outcomes
the change in distance and the lowest SpO2 during 6-minute walk test, pulmonary function tests (FVC and diffusing capacity of the lung for carbon monoxide),serum levels of the markers (KL-6 and surfactant protein -D), quality of life, the rate of acute exacerbation, the time to the first acute exacerbation, progression-free survival time and survival time over 52-week after treatment with Nintedanib
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of 150mg of nintedanib twice daily
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who fulfilled all of the following criteria
1. Age is more than 40 years old.
2. After receiving enough explanations about participation in this study, the document consents by free will of patient were received thorough his understanding.
3)Satisfy the diagnostic official ATS/ERS/JRS/ALAT statement criteria of IPF, using HRCT or surgical biopsy.
4)Disease activity is stable at registration
5)Patient who need treatment with nintedanib and agree to the administration.
6)Cases who are expected 12 months or more survival after the treatment of nintedanib.
Key exclusion criteria
1) AST/ALT/T-bil are is more than reference value 2.5 times
2)Patient who was determined as ineligible by the investigator or the subinvestigator.
3) The patients who has already received corticosteroid (over 10mg/day), immunosupressant, N-acetylcysteine , pirfenidone, and other treatment for IPF
4) Active infection and other severe complication
5) Malignant tumor
6) case was determined as ineligible by attending physician
Target sample size
30
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 | Hideya Kitamura |
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
hideyak5555@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
| 2016 | Year | 01 | Month | 25 | 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 | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 26 | 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
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2016 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023054
