UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052260 |
|---|---|
| Receipt number | R000059660 |
| Scientific Title | An observational study to analyze the pharmacokinetics of Nintedanib and to elucidate the relationship between the safety and efficacy of the drug in the real world. |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2025/03/22 15:59:19 |
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Basic information
Public title
An observational study to determine the relationship between blood concentrations of Nintedanib and the safety of the drug in the real world.
Acronym
Observational study to elucidate the relationship between blood concentration and safety of Nintedanib
Scientific Title
An observational study to analyze the pharmacokinetics of Nintedanib and to elucidate the relationship between the safety and efficacy of the drug in the real world.
Scientific Title:Acronym
An observational study to elucidate the relationship between the pharmacokinetics of Nintedanib and the safety and efficacy of the drug.
Region
| Japan |
Condition
Condition
interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between Nintedanib blood concentrations and adverse drug reactions in patients taking Nintedanib.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between blood levels of Nintedanib and the occurrence of adverse effects.
Key secondary outcomes
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 meet all of the following criteria are eligible:
1. Patients who have been continuously taking Nintedanib for at least 3 days.
2. Patients who have provided their consent to participate in this study by signing a consent form themselves or through a proxy.
Key exclusion criteria
1. Individuals deemed unsuitable by the principal investigator and co-investigators.
2. Those who were unable to provide consent for this research.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Yasui |
Organization
Hamamatsu University Hospital
Division name
Division of Respiratory Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
Homepage URL
yasui@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi, Hamamatsu, Shizuoka, Japan
Tel
053-435-2263
yasui@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 20 | 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
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2027 | 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: The association between blood concentration of Nintedanib and the occurrence of adverse events.
Management information
Registered date
| 2023 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059660
