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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name