UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047083 |
|---|---|
| Receipt number | R000053704 |
| Scientific Title | Antibody response to SARS-CoV-2 after the second and third doses of mRNA COVID-19 vaccine in Japanese hemodialysis patients |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/04/14 18:54:44 |
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Basic information
Public title
Robust antibody response after 3 doses of mRNA COVID-19 vaccine in hemodialysis patients
Acronym
Effects after administration of corona vaccine in hemodialysis patients
Scientific Title
Antibody response to SARS-CoV-2 after the second and third doses of mRNA COVID-19 vaccine in Japanese hemodialysis patients
Scientific Title:Acronym
Effects after mRNA COVID-19 vaccine administration in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy test of mRNA COVID-19 vaccine in Japanese hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of increase in SARS-CoV-2 antibody titer after mRNA COVID-19 vaccination
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
Patients on hemodialysis 3 times a week in our hospital
Key exclusion criteria
Patients with no history of COVID-19
Target sample size
283
Research contact person
Name of lead principal investigator
| 1st name | Ryochi |
| Middle name | |
| Last name | Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7 Houei, Fukui-shi
TEL
0776211277
ryoichi@mitene.or.jp
Public contact
Name of contact person
| 1st name | Ryochi |
| Middle name | |
| Last name | Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7 Houei, Fukui-shi
TEL
1776211277
Homepage URL
http://www.fujita-mhp.jp/
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Memorial 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
Fukui General Hospital
Address
58-16-1, Enami-cho, Fukui City
Tel
0776-59-1300
chiey@mx3.fctv.ne.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
藤田記念病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://rrtjournal.biomedcentral.com
Number of participants that the trial has enrolled
283
Results
Significant SARS-CoV-2 antibody production is observed in hemodialysis patients after three doses of mRNA COVID-19 vaccine.
Results date posted
| 2022 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 08 | Month | 01 | Day |
Baseline Characteristics
167 hemodialysis patients and 100 health care workers
Participant flow
Adverse events
The second and third vaccinations did not differ significantly between the two groups.
Outcome measures
Analysis of post-vaccine SARS-CoV-2 IgG antibody titers and related factors
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 02 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 02 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 28 | Day |
Other
Other related information
Approximately 6 months after two doses of mRNA COVID-19 vaccine, a third dose of the mRNA COVID-19 vaccine will be added, and subsequent SARS-CoV-2 antibodies and adverse events will be investigated. Factors related to antibody elevation will be examined, including age before the third vaccination, serum albumin level, lymphocyte count, PCR, nPCR, GNRI, Cr Index, and BMI.
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053704
