UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046281 |
|---|---|
| Receipt number | R000052733 |
| Scientific Title | Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis |
| Date of disclosure of the study information | 2021/12/05 |
| Last modified on | 2021/12/03 15:54:33 |
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Basic information
Public title
Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Acronym
Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Scientific Title
Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Scientific Title:Acronym
Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in spike protein antibody titer
Key secondary outcomes
Changes in antibody titer of patients with in-center dialysis
Changes in antibody titer of patients with home dialysis
Analysis of factors that affect changes in spike protein antibody titer
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
1) Dialysis patients who regularly visited the study center or home dialysis patients who are regularly examined by the attending physician.
2) Patients who received the first vaccine dose in June 2021.
Key exclusion criteria
1)Patients who have been infected with SARS-CoV-2.
2)Patients who received only one vaccine dose.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Wakai |
Organization
Reiseikai Medical Corporation Shinagawa Garden Clinic
Division name
N/A
Zip code
141-0032
Address
Imasu Ohsaki Building 2F, 1-20-3, Ohsaki, Shinagawa, Tokyo
TEL
03-3779-4970
umin@reiseikai.org
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Wakai |
Organization
Reiseikai Medical Corporation Shinagawa Garden Clinic
Division name
N/A
Zip code
141-0032
Address
Imasu Ohsaki Building 2F, 1-20-3, Ohsaki, Shinagawa, Tokyo
TEL
03-3779-4970
Homepage URL
umin@reiseikai.org
Sponsor or person
Institute
Reiseikai Medical Corporation Shinagawa Garden Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Reiseikai Medical Corporation Gotanda Garden Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Reiseikai Medical Corporation
Address
Imasu Ohsaki Building 2F, 1-20-3, Ohsaki, Shinagawa, Tokyo
Tel
03-3779-4970
umin@reiseikai.org
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
医療法人社団麗星会品川ガーデンクリニック、医療法人社団麗星会五反田ガーデンクリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 05 | 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
96
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Antibody levels were measured using residual samples of the blood collected for routine tests at dialysis sessions. This study involved no invasion or intervention to patients and used only information such as medical information and residual samples.
Management information
Registered date
| 2021 | Year | 12 | Month | 04 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052733
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
