UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058245 |
|---|---|
| Receipt number | R000066497 |
| Scientific Title | Longitudinal Changes in Antibody Titers Induced by COVID-19 Vaccination in hemodialysis patients |
| Date of disclosure of the study information | 2025/06/22 |
| Last modified on | 2025/06/21 19:24:37 |
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Basic information
Public title
Longitudinal Changes in Antibody Titers Induced by COVID-19 Vaccination in hemodialysis patients
Acronym
Longitudinal Changes in Antibody Titers Induced by COVID-19 Vaccination in hemodialysis patients
Scientific Title
Longitudinal Changes in Antibody Titers Induced by COVID-19 Vaccination in hemodialysis patients
Scientific Title:Acronym
Longitudinal Changes in Antibody Titers Induced by COVID-19 Vaccination in hemodialysis patients
Region
| Japan |
Condition
Condition
COVID-19, Hemodialysis
Classification by specialty
| Nephrology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare SARS-CoV-2 antibody titers after COVID-19 vaccination between dialysis and non-dialysis patients, and to analyze factors influencing antibody levels
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 antibody titers will be measured using serum samples collected at the following time points: before the first vaccination, before the second vaccination, 2 weeks after the second vaccination, 3 months after the second vaccination, 6 months after the second vaccination, 1 month after the third vaccination, and 3 months after the third 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
[Dialysis Group]
Outpatients undergoing dialysis at facilities that responded to the open call for participation posted on the Japanese Society for Dialysis Therapy (JSDT) website and who provided informed consent to participate in this study (on a first-come, first-served basis).
[Control Group]
Non-dialysis individuals who provided informed consent to participate (on a first-come, first-served basis), including patients attending hospitals or clinics affiliated with the JSDT, their family members, staff of these facilities, and staff or residents of affiliated nursing homes (with consent obtained from both the individual and their family, as applicable).
Additionally, participants in both groups must be individuals who plan to receive the Pfizer-BioNTech COVID-19 vaccine (BNT162b2), have not yet received any doses at the time of consent, and are willing to complete all seven study visits over the course of one year.
Key exclusion criteria
[Control Group]
Individuals will be excluded if they have an eGFR <45 mL/min/1.73 m2, have been diagnosed with nephrotic syndrome, have a history of cancer treatment within the past year, or are receiving steroids or immunosuppressive therapy.
[Dialysis Group]
Individuals will be excluded if they have a history of cancer treatment within the past year or are receiving steroids or immunosuppressive therapy.
Target sample size
329
Research contact person
Name of lead principal investigator
| 1st name | Munekazu |
| Middle name | |
| Last name | Ryuzaki |
Organization
the Japanese Society for Dialysis Therapy
Division name
Infection Control Committee
Zip code
113-0033
Address
2-38-21 Hongo, Bunkyo-ku,Tokyo
TEL
+81-3-5800-0786
jsdt.vaccine.antibody@gmail.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Yoshifuji |
Organization
Tokyo Saiseikai Central Hospital
Division name
Nephrology
Zip code
108-0073
Address
1-4-17 Mita Mimato-ku,Tokyo
TEL
+81-3-3451-8211
Homepage URL
jsdt.vaccine.antibody@gmail.com
Sponsor or person
Institute
the Japanese Society for Dialysis Therapy
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society for Dialysis Therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japanese Society for Dialysis Therapy
Address
2-38-21 Hongo Bunkyo-ku,Tokyo
Tel
+81-3-5800-0786
sonota@jsdt.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-008
Org. issuing International ID_1
Research Ethics Committee,Tokyo Saiseikai Central Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.jsdt.or.jp/tools/file/download.cgi/2852/03%20%E7%A0%94%E7%A9%B6%E5%8F%82%E5%8A%A0%E8%80%
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC9388964/
Number of participants that the trial has enrolled
329
Results
HD patients had significantly lower antibody titers than age- and sex-matched non-dialysis individuals over 3 months after primary vaccination. Dialysis time was identified as a factor affecting SARS-CoV-2 IgG titers in HD group, with longer dialysis time resulting in higher maximum SARS-CoV-2 IgG titers.
Results date posted
| 2025 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hemodialysis patients (HD group) and age- and sex-matched non-dialysis individuals (Control group), receiving two doses of BNT162b2 vaccine, were recruited.
Participant flow
The Japanese Society for Dialysis Therapy (JSDT) Web site from July 2021
Adverse events
No serious adverse events related to the vaccination
Outcome measures
Anti-SARS-CoV-2 immunoglobulin (IgG) (SARS-CoV-2 IgG titers) before vaccination, 3 weeks after the first vaccination, 2 weeks after the second vaccination, and 3 months after the second vaccination between Control group and HD group
Factors affecting SARS-CoV-2 IgG titers
Adverse reactions in Control and HD groups
The relationship between adverse reactions and SARS-CoV-2 IgG titers
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will provide blood samples for the evaluation of antibody levels. In addition, participants will be asked to fill out a questionnaire on any adverse reactions.
Management information
Registered date
| 2025 | Year | 06 | Month | 21 | Day |
Last modified on
| 2025 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066497
