UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019751 |
|---|---|
| Receipt number | R000022801 |
| Scientific Title | Prospective study of predictor for efficiency of treatment with Nintedanib for idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2024/05/18 12:44:20 |
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Basic information
Public title
Prospective study of predictor for efficiency of treatment with Nintedanib for idiopathic pulmonary fibrosis
Acronym
Study of predictor for treatment with Nintedanib
Scientific Title
Prospective study of predictor for efficiency of treatment with Nintedanib for idiopathic pulmonary fibrosis
Scientific Title:Acronym
Study of predictor for treatment with Nintedanib
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of biomarker for efficiency of treatment with Nintedanib for idiopathic pulmonary fibrosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between serum periostin level and change of pulmonary function
Key secondary outcomes
1. The correlation between serum periostin level and clinical data except for pulmonary function
2. Predictors of overall survival and progression-free-survival
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The case with idiopathic pulmonary fibrosis who visited to the hospitals participated to this study.
Patients who fulfilled all of the following criteria
1. Age is more than 40 years old.
2. After receiving enough explanations about participation in the study, there was the document consent by free will of patients thorough his enough understanding.
3. Patient who was diagnosed as idiopathic pulmonary fibrosis by criteria of this study
4. Disease activity is stable at registration
5. Patient who need treatment with nintedanib
6. Patient who can be treated with nintedanib within 2 weeks from obtaining informed consent
Key exclusion criteria
The patients who fulfilled one of the following criteria
1. Pregnant women.
2. Patient who was determined as ineligible by the investigator or the subinvestigator.
3. Patients treated with the following drug at the start of observation.
Corticosteroid (more than 10 mg per day in term of prednizolone)
Immunosuppressant
N-acetylcysteine
Pirfenidone
Study drug for idiopathic pulmonary fibrosis
4. Case with exclusion disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Hoshino |
Organization
Kurume University, School of Medicine
Division name
Division of Respirology, Neurology and Rheumotology, Department of Internal Medicine
Zip code
8300011
Address
Asahi-machi 67, Kurume, Japan
TEL
81-942-31-7560
hoshino@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Okamoto |
Organization
Kurume University, School of Medicine
Division name
Division of Respirology, Neurology and Rheumotology, Department of Internal Medicine
Zip code
8300011
Address
Asahi-machi 67, Kurume, Japan
TEL
81-942-31-7560
Homepage URL
okamoto_masaki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Respirology, Neurology and Rheumotology, Department of Internal Medicine, Kurume University, School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Radiology and Center for Diagnostic Imaging, Kurume University, School of Medicine
Department of Radiology, Kinki Central Hospital of the Mutual Aid Association of Public School Teachers
Second Department of Internal Medicine, Nagasaki University, School of Medicine
Department of Pathology, Nagasaki University, School of Medicine
Department of Respiratory Medicine and Allergy, Tosei General Hospital
Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University
Department of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine
Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center
Kirigaoka Tsuda Hospital
The First Department of Internal Medicine, Shinshu University School of Medicine
Division of Pathology, Saitama Cardiovascular Respiratory Centre
Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine
Japan Community Health care Organization (JCHO) Kurume General Hospital
Institute for Advancement of Clinical and Translational Science, Kyoto University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Academic Research Organization of Kurume University
Address
Asahi-machi 67, Kurume, Fukuoka
Tel
0942-35-3311
i_rinri@kurume-u.ac.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
久留米大学病院 (福岡県)
長崎大学病院 (長崎県)
産業医科大学 (福岡県)
公立陶生病院 (愛知県)
大阪市立大学病院 (大阪府)
札幌医科大学病院 (北海道)
神奈川県立循環器呼吸器病センター (神奈川県)
信州大学病院 (長野県)
大分大学病院 (大分県)
九州大学病院 (福岡県)
広島大学病院 (広島県)
天理よろづ相談所病院 (奈良県)
国立病院機構東京病院 (東京都)
NHO近畿中央胸部疾患センター (大阪府)
浜松医科大学 (静岡県)
東邦大学医療センター大森病院 (東京都)
獨協医科大学 (栃木県)
NHO茨城東病院 (茨城県)
富山大学附属病院 (富山県)
沖縄県立中部病院 (沖縄県)
順天堂大学医学部 (東京都)
京都大学病院 (京都府)
福島県立医科大学 (福島県)
高知大学病院 (高知県)
東京医科歯科大学 (東京都)
福岡大学病院 (福岡県)
日本医科大学病院 (東京都)
北海道大学病院 (北海道)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
doi: 10.1038/s41598-023-49180-4.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1038/s41598-023-49180-4.
Number of participants that the trial has enrolled
87
Results
Periostin levels measured by ELISA in 87 eligible patients who participated in a multicenter prospective study were not significantly associated with the change in pulmoary function and were independent predictors of overall survival. In the analysis of nintedanib effectiveness, higher binarized monomeric periostin levels were associated with more favorable suppressive effects on decreased pulmoary function in the treatment group compared with historical controls.
Results date posted
| 2024 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 112 patients with idiopathic pulmonary fibrosis who participated to this study, 87 paients met to inclusion criteria and registrated.
Participant flow
Patients with idiopathic pulmonary fibrosis who recieved nintedanib in faculties that participated to this study were regisrated.
Adverse events
Common rate and kind of side effects from nintedanib were shown.
Outcome measures
Association among serum periostin levels, decrease in pulmonary function, and overall survival.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 18 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 18 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 18 | Day |
Other
Other related information
This study was a cohort study to analyze the clinical data and preserve sera.
Study design
Prospective cohort study
Subjects
Patients with idiopathic pulmonary
fibrosis who visited collaborative study
hospitals from November 2015 until
September 2018
Measuring substance
Serum levels of periostin
Management information
Registered date
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022801
