UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047360 |
|---|---|
| Receipt number | R000054017 |
| Scientific Title | Multi-center prospective observational study for analysis of efficacy and safety of SARS-CoV-2 vaccine in kidney transplant recipients |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/04/10 09:50:26 |
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Basic information
Public title
Multi-center prospective observational study for analysis of efficacy and safety of SARS-CoV-2 vaccine in kidney transplant recipients
Acronym
SVKTR observational study
Scientific Title
Multi-center prospective observational study for analysis of efficacy and safety of SARS-CoV-2 vaccine in kidney transplant recipients
Scientific Title:Acronym
SVKTR PROS study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (Post Kidney Transplantation)
Classification by specialty
| Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of SARS-CoV-2 vaccine in kidney transplant recipients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody positive rate among kidney transplant recipients with antibody negatives before vaccination. (After 4 weeks after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1: Adult patient at the time of consent acquisition.
2: Patients who have received sufficient explanation in participating in this study, and who have obtained the patient's free will to consent to the document after sufficient understanding.
Key exclusion criteria
1: Patients under 20 years.
2: Patients with SARS-CoV-2 infection prior to vaccination.
3: Patients vaccinated with other vaccines within 2 weeks before and after SARS-CoV-2 vaccination.
4: Patients judged by the principal investigator to be inappropriate as subjects
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Sasaki |
Organization
Sapporo City General Hospital
Division name
Department of Kidney Transplant Surgery
Zip code
060-8604
Address
Nishi 13 chome-1 kita 11 jo, Chuo Ward, Sapporo
TEL
011-726-2211
hajimes1207@hotmail.com
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Sasaki |
Organization
Sapporo City General Hospital
Division name
Department of Kidney Transplant Surgery
Zip code
060-8604
Address
Nishi 13 chome-1 kita 11 jo, Chuo Ward, Sapporo
TEL
011-726-2211
Homepage URL
hajimes1207@hotmail.com
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo City General Hospital
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
Sapporo City General Hospital
Address
Nishi 13 chome-1 kita 11 jo, Chuo Ward, Sapporo
Tel
011-726-2211
hiroshi.tanaka@doc.city.sapporo.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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
doi: 10.1016/j.transproceed.2023.02.018.
Number of participants that the trial has enrolled
400
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
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1: Regarding the efficacy of the vaccine, COVID-19 incidence rate, COVID-19 hospitalization rate, COVID-19 severity classification, patient survival rate, presence or absence of acute kidney injury secondary to COVID-19
2: Regarding the persistence of vaccine effect, antibody-positive individuals will be measured every 4-8 weeks after positive confirmation for up to 24 weeks.
3: Vaccine adverse events include fever, malaise, swelling at the inoculation site, myalgia, headache, and other adverse events. The extent of adverse events is recorded based on CTCAE v5.0.
Management information
Registered date
| 2022 | Year | 04 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
