UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043384 |
|---|---|
| Receipt number | R000049470 |
| Scientific Title | The clinical impact of Nintedanib and Pirfenidone on pulmonary circulation of interstitial pneumonia: A Hyogo-IP multicenter prospective observational study |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/02/28 14:28:59 |
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Basic information
Public title
The clinical impact of Nintedanib and Pirfenidone on pulmonary circulation of interstitial pneumonia: A Hyogo-IP multicenter prospective observational study
Acronym
The clinical impact of Nintedanib and Pirfenidone on pulmonary circulation of interstitial pneumonia: A Hyogo-IP multicenter prospective observational study
Scientific Title
The clinical impact of Nintedanib and Pirfenidone on pulmonary circulation of interstitial pneumonia: A Hyogo-IP multicenter prospective observational study
Scientific Title:Acronym
The clinical impact of Nintedanib and Pirfenidone on pulmonary circulation of interstitial pneumonia: A Hyogo-IP multicenter prospective observational study
Region
| Japan |
Condition
Condition
Interstitial pneumonia
Classification by specialty
| Cardiology | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical impact of antifibrotics on the pulmonary circulation of interstitial pneumonia.
Basic objectives2
Others
Basic objectives -Others
To investigate the risk factors for pulmonary hypertension in patients with interstitial pneumonia with or without antifibrotics.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Tricuspid regurgitation pressure gradient (TRPG) in patients treated with or without antifibrotics on the 12th month.
Key secondary outcomes
Pulmonary vascular resistance (PVR) in patients treated with or without antifibrotics on the 12th month.
To identify the risk factors for pulmonary hypertension.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with interstitial pneumonia during this study period and
(1) newly start Pirfenidone or Nintedanib.
or
(2) are not treated with antifibrotics.
Key exclusion criteria
(1) Patients who refuse to participate in this study.
(2) Patient whose clinician considered inappropriate for this study for any other reasons.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakayama |
Organization
Shinko Hospital
Division name
Department of cardiology
Zip code
6510072
Address
Wakinohama-cho 1-4-47,Chuo-ku, Kobe, Hyogo, Japan
TEL
+81-78-261-6711
nakayama.kazuhiko@shinkohp.or.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakayama |
Organization
Shinko Hospital
Division name
Department of cardiology
Zip code
6510072
Address
Wakinohama-cho 1-4-47,Chuo-ku, Kobe, Hyogo, Japan
TEL
+81-78-261-6711
Homepage URL
https://shinkohp.jp/about/ethics
nakayama.kazuhiko@shinkohp.or.jp
Sponsor or person
Institute
Shinko Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Update when added.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinko Hospital
Address
Wakinohama-cho 1-4-47,Chuo-ku, Kobe, Hyogo, Japan
Tel
+81-78-261-6711
yamagami.hiroko@shinkohp.or.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
神鋼記念病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint: TRPG
Secondary endpoint: PVR, related clinical parameters
Management information
Registered date
| 2021 | Year | 02 | Month | 19 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049470
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
