UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054103 |
|---|---|
| Receipt number | R000061766 |
| Scientific Title | COVID-19 breakthrough infection in hemodialysis patients during an Omicron epidemic: a single hemodialysis center experience. |
| Date of disclosure of the study information | 2024/04/11 |
| Last modified on | 2024/04/10 14:04:13 |
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Basic information
Public title
COVI-19 breakthrough infection in hemodialysis patients during an Omicron epidemic
Acronym
COVID-19 breakthrough infection in hemodialysis patients during an Omicron epidemic
Scientific Title
COVID-19 breakthrough infection in hemodialysis patients during an Omicron epidemic: a single hemodialysis center experience.
Scientific Title:Acronym
COVID-19 breakthrough infection in hemodialysis patients during an Omicron epidemic
Region
| Japan |
Condition
Condition
COVID-19 breakthrough infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Status of COVID-19 breakthrough infection in hemodialysis patients and its prognosis and comparison with non-iInfected patients
Basic objectives2
Others
Basic objectives -Others
We examined the age, gender, dialysis history, diabetes status, and lymphocyte counts of hemodialysis patients and contrasted hemodialysis patients with COVID-19 breakthrough infection to those who are not infected.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Factors that differentiate breakthrough-infected and non-Infected individuals
Key secondary outcomes
Prognosis of breakthrough-infected and non-iInfected patients
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Maintenance hemodialysis patients at our hemodialysis center who agreed to participate in this study
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
0776211277
ryoichi@mitene.or.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
0776211277
Homepage URL
http://www.fujita-mhp.jp/
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital
Institute
Department
Personal name
Ryoichi Miyazaki
Funding Source
Organization
Fujita Memorial Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui General Hospital
Address
58-16-1, Egami-cho, Fukui City
Tel
0776591300
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
https://rrtjournal.biomedcentral.com
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
207
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
We also surveyed symptoms of COVID-19-affected hemodialysis patients 3 months post-affection.
Management information
Registered date
| 2024 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061766
| 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 |
