UMIN-CTR Clinical Trial

Basic information
Public title	Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Acronym	Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Scientific Title	Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Scientific Title:Acronym	Changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify changes in antibody titer after SARS-CoV-2 vaccination of patients with in-center and home dialysis
Basic objectives2	Others
Basic objectives -Others	epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in spike protein antibody titer
Key secondary outcomes	Changes in antibody titer of patients with in-center dialysis Changes in antibody titer of patients with home dialysis Analysis of factors that affect changes in spike protein antibody titer

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	1) Dialysis patients who regularly visited the study center or home dialysis patients who are regularly examined by the attending physician. 2) Patients who received the first vaccine dose in June 2021.
Key exclusion criteria	1)Patients who have been infected with SARS-CoV-2. 2)Patients who received only one vaccine dose.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Haruki Middle name Last name Wakai
Organization	Reiseikai Medical Corporation Shinagawa Garden Clinic
Division name	N/A
Zip code	141-0032
Address	Imasu Ohsaki Building 2F, 1-20-3, Ohsaki, Shinagawa, Tokyo
TEL	03-3779-4970
Email	umin@reiseikai.org

Public contact
Name of contact person	1st name Haruki Middle name Last name Wakai
Organization	Reiseikai Medical Corporation Shinagawa Garden Clinic
Division name	N/A
Zip code	141-0032
Address	Imasu Ohsaki Building 2F, 1-20-3, Ohsaki, Shinagawa, Tokyo
TEL	03-3779-4970
Homepage URL
Email	umin@reiseikai.org

Sponsor
Institute	Reiseikai Medical Corporation Shinagawa Garden Clinic
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Reiseikai Medical Corporation Gotanda Garden Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethics committee of Reiseikai Medical Corporation
Address	Imasu Ohsaki Building 2F, 1-20-3, Ohsaki, Shinagawa, Tokyo
Tel	03-3779-4970
Email	umin@reiseikai.org

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	医療法人社団麗星会品川ガーデンクリニック、医療法人社団麗星会五反田ガーデンクリニック

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 05 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	96
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	No longer recruiting
Date of protocol fixation	2021 Year 06 Month 25 Day
Date of IRB	2021 Year 07 Month 02 Day
Anticipated trial start date	2021 Year 07 Month 03 Day
Last follow-up date	2022 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Antibody levels were measured using residual samples of the blood collected for routine tests at dialysis sessions. This study involved no invasion or intervention to patients and used only information such as medical information and residual samples.

Management information
Registered date	2021 Year 12 Month 04 Day
Last modified on	2021 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052733