UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043368 |
|---|---|
| Receipt number | R000049503 |
| Scientific Title | Response rate to SARS-CoV-2 (COVID-19) vaccine in dialysis patients. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/08/20 09:18:16 |
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Basic information
Public title
Response rate to SARS-CoV-2 (COVID-19) vaccine in dialysis patients.
Acronym
Response rate to SARS-CoV-2 (COVID-19) vaccine in dialysis patients.
Scientific Title
Response rate to SARS-CoV-2 (COVID-19) vaccine in dialysis patients.
Scientific Title:Acronym
Response rate to SARS-CoV-2 (COVID-19) vaccine in dialysis patients.
Region
| Japan |
Condition
Condition
Dialysis patients
Classification by specialty
| Medicine in general | Pneumology | Nephrology |
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the response rate to SARS-CoV-2 vaccine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positivity rate of SARS-CoV-2 neutralizing antibody in dialysis patients 12 weeks after vaccination.
Key secondary outcomes
Positivity rate of SARS-CoV-2 neutralizing antibody in dialysis patients before, 3 weeks after the booster and 4th vaccination, and 48 weeks after the last 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis, peritoneal dialysis patients/Healthy controls with written informed consent.
Key exclusion criteria
Patients who are not likely to survive at least 1 year.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Takazono |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
852-8102
Address
1-7-1, Sakamoto, Nagasaki
TEL
0958197273
takahiro-takazono@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Takazono |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
852-8102
Address
1-7-1, Sakamoto, Nagasaki
TEL
0958197273
Homepage URL
takahiro-takazono@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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
| 2021 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational case control study
Subject: hemodialysis patients, peritoneal dialysis patients, healthy volunteers
Measure the neutralizing antibody levels before vaccination and 3, 12, 48 weeks after vaccination.
Management information
Registered date
| 2021 | Year | 02 | Month | 18 | Day |
Last modified on
| 2022 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049503
