UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056059 |
|---|---|
| Receipt number | R000064061 |
| Scientific Title | Tolerability of nintedanib in patients with interstitial lung disease at our hospital and risk factors for discontinuation due to adverse events |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/05 17:13:24 |
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Basic information
Public title
Tolerability of nintedanib in patients with interstitial lung disease at our hospital and risk factors for discontinuation due to adverse events
Acronym
Tolerability of nintedanib in patients with interstitial lung disease at our hospital and risk factors for discontinuation due to adverse events
Scientific Title
Tolerability of nintedanib in patients with interstitial lung disease at our hospital and risk factors for discontinuation due to adverse events
Scientific Title:Acronym
Tolerability of nintedanib in patients with interstitial lung disease at our hospital and risk factors for discontinuation due to adverse events
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the tolerability of nintedanib in patients with interstitial lung disease at our hospital and risk factors for discontinuation due to adverse events.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of Nintedanib Administration
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study included all patients who were prescribed nintedanib for interstitial lung disease at the respiratory medicine department of our hospital.
Key exclusion criteria
none
Target sample size
131
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
respiratory24@outlook.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
Homepage URL
respiratory24@outlook.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
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
Matsuyama Red Cross Hospital
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
Tel
0899241111
respiratory24@outlook.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
| 2024 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.matsuyama.jrc.or.jp/aboutus/clinical_research/
Publication of results
Published
Result
URL related to results and publications
https://www.matsuyama.jrc.or.jp/aboutus/clinical_research/
Number of participants that the trial has enrolled
131
Results
The discontinuation rate of nintedanib reached 62.5%, which was higher than the rates reported in previous studies; 30.5% of patients discontinued nintedanib due to adverse events. Patients were older and had lower body surface area, and body mass index than those reported in previous studies. Male sex was a significant risk factor for shorter durations of nintedanib treatment in both cause-specific proportional hazards models and Fine-Gray models.
Results date posted
| 2024 | Year | 11 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
At our hospital, nintedanib was prescribed in 131 cases by February 2023.
Participant flow
The median duration of nintedanib administration was 294 days, and 30% continued for more than 2 years.
Adverse events
Adverse events led to discontinuation in 40 cases (30.5%), deterioration of general condition in 38 cases (29.0%), and other reasons in 4 cases (3.0%). Adverse events leading to discontinuation included diarrhea in 19 cases, decreased appetite in 10 cases, abdominal pain in 4 cases, drug rash in 4 cases, nausea in 3 cases, liver disorder in 2 cases, vomiting in 1 case, and thrombocytopenia in 1 case (including multiple cases).
Outcome measures
Discontinuation due to adverse events was considered an event, and discontinuation due to reasons other than adverse events, such as deterioration of overall condition, was considered an event and analyzed using a proportional hazards model.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients prescribed nintedanib for interstitial lung disease at the respiratory medicine department of our hospital were included in the study. Data from 131 patients were obtained between February 2018 and February 2023. A retrospective analysis was performed using medical records. Survey items included patient background, respiratory function, comorbidities, and nintedanib administration status at the time of initiation of nintedanib administration. Cause-specific proportional hazards models were used with the duration of nintedanib administration as the objective variable, and discontinuation due to adverse events was considered as an event, and discontinuation due to causes other than adverse events, such as deterioration of general condition, was censored. Correlation analysis between explanatory variables was performed using Spearman's rank correlation coefficient, and one of the explanatory variables with correlation was adopted to avoid the problem of multicollinearity. As a sensitivity analysis, Fine-Gray models were used to analyze the proportional hazards model, in which discontinuation due to adverse events was considered as an event, discontinuation due to deterioration of general condition was considered as a competing risk, and discontinuation due to other causes was censored.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064061
