UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052167 |
|---|---|
| Receipt number | R000059536 |
| Scientific Title | The Prognostic Impact of COVID-19 Incidence, the Effectiveness of SARS-CoV-2 Vaccine, and Factors that may Prevent Vaccination in Japanese Dialysis Patients |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2024/04/26 16:30:42 |
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Basic information
Public title
The Prognostic Impact of COVID-19 Incidence, the Effectiveness of SARS-CoV-2 Vaccine, and Factors that may Prevent Vaccination in Japanese Dialysis Patients
Acronym
The Impact of COVID-19 on Dialysis Patients and Factors Associated with its Vaccination.
Scientific Title
The Prognostic Impact of COVID-19 Incidence, the Effectiveness of SARS-CoV-2 Vaccine, and Factors that may Prevent Vaccination in Japanese Dialysis Patients
Scientific Title:Acronym
The Impact of COVID-19 on Dialysis Patients and Factors Associated with its Vaccination.
Region
| Japan |
Condition
Condition
End-stage kidney disease under hemodialysis therapy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of COVID-19 morbidity, cardiovascular event incidence, and mortality by vaccination against COVID-19
Basic objectives2
Others
Basic objectives -Others
The objective is to analyze COVID-19 morbidity, cardiovascular event incidence, and mortality due to vaccination against COVID-19, after adjustment by patient background factors. At the same time, we also aim to analyze cardiovascular event incidence and mortality due to COVID-19 morbidity and to investigate items related to factors associated with vaccination avoidance(factors that inhibit vaccination).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COVID-19 morbidity and mortality after COVID-19 vaccination
Key secondary outcomes
Cardiovascular disease incidence after COVID-19 morbidity
Mortality after COVID-19 incidence
Cardiovascular disease incidence after COVID-19 vaccination
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
In the database study, all patients included in the Japan Society for Dialysis Therapy statistical survey who are at least 18 years old, have been on dialysis for at least 3 months, and meet the criteria of 3 dialysis cycles per week.
In the questionnaire survey, patients who meet the following criteria: age 18 years or older, dialysis history of at least 3 months, and number of dialysis cycles per week of times per week, among the patients who are currently attending the study's collaborating institution.
In the interview survey, patients who were unvaccinated or who were unvaccinated but were vaccinated based on some trigger among the patients who participated in the questionnaire survey.
Key exclusion criteria
In any survey, if the applicant is under 18 years of age. In addition, if the person is determined to lack the capacity to give informed consent, for example, if he/she has a diagnosis of dementia.
Target sample size
365000
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Sugawara |
Organization
The University of Tokyo Hospital
Division name
Division of Nephrology and Endocrinology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo-to
TEL
03-3815-5411
ysuga-tky@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Sugawara |
Organization
The University of Tokyo Hospital
Division name
Division of Nephrology and Endocrinology
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo-to
TEL
03-3815-5411
Homepage URL
jinnai.research.assist@gmail.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo-to
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 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
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database Survey
The following analyses will be conducted using data from the Japan Society for Dialysis Therapy statistical survey.
A-1. Examination of the effect of COVID-19 vaccination on COVID-19 morbidity
A-2. Examination of the effect of COVID-19 vaccination on the incidence of cardiovascular events
A-3. Examination of the effect of COVID-19 vaccination on fatality rate
B-1. Study of the effect of COVID-19 on the incidence of cardiovascular events
B-2. study of the effect of COVID-19 on fatality rate
Questionnaire survey
After collecting more detailed information, we will conduct the same analysis as in A-1, A-2, and B-1 above. Reasons for vaccination and reasons for not being vaccinated will also be investigated, as well as factors related to vaccination (factors that inhibit vaccination).
Consent will be obtained for cases attending the study's collaborating institution. If they consent, they will be asked to complete an online questionnaire. The questionnaire does not contain any personal information, but the case numbers of the patients in the study will be entered. At the same time that the individual answers the questionnaire, the principal investigator/associate investigator/research collaborator (who has access to the medical records) will collect basic information, disease incidence information, vaccination status, and other information from the medical record, and enter it into a web-based response system on the web, such as google form.
Interview survey
For cases who were unvaccinated, or who were unvaccinated but were vaccinated for some reason, an interview survey will be conducted to determine the reasons why they were not vaccinated and the reasons why they were vaccinated. Documented consent will be newly obtained. Conduct an online interview survey of 30 minutes or less with the Principal Investigator or Research Supervisor and the case concerned.
Management information
Registered date
| 2023 | Year | 09 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059536
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