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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036828
Receipt No. R000041933
Scientific Title Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of patients after kidney transplantation
Date of disclosure of the study information 2019/05/24
Last modified on 2019/05/23

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Basic information
Public title Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of patients after kidney transplantation
Acronym Abbott RealTime CMV Domestic Clinical Performance Trial
Scientific Title Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of patients after kidney transplantation
Scientific Title:Acronym Abbott RealTime CMV Domestic Clinical Performance Trial
Region
Japan

Condition
Condition Kidney Transplantation
Classification by specialty
Surgery in general Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the clinical utility of Abbott RealTime CMV in monitoring CMV infection of patients after kidney transplantation
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity and specificity in the detection of CMV infection using Abbott RealTime CMV (when antigenemia is a standard method)
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 Adults of age 20 or older
Patients scheduled for kindney transplantation
Consent form obtained
Key exclusion criteria Patients who may be unable to make the follow-up hospital visits
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shohei
Middle name
Last name Fuchinoue
Organization Tokyo Women's University Hospital
Division name Department of Kidney surgery
Zip code 162-8666
Address 8-1 kawadachou, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email sfuchi@twmu.ac.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Seki
Organization Abbott Japan Co., Ltd.
Division name Molecular Division
Zip code 108-6305
Address 3-5-27 Mita, Minato-ku, Tokyo
TEL 03-4555-1099
Homepage URL
Email yutaka.seki@abbott.com

Sponsor
Institute Abbott Japan Co., Ltd.
Institute
Department

Funding Source
Organization Abbott Japan Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Women's Medical University, Institutional Review Board
Address 8-1 kawadacho, shinjuku-ku, Tokyo
Tel 03-5269-7839
Email chiken.bm@twmu.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
2019 Year 05 Month 24 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 50
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
2017 Year 07 Month 25 Day
Date of IRB
2017 Year 09 Month 13 Day
Anticipated trial start date
2017 Year 09 Month 27 Day
Last follow-up date
2018 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: A prospective non-interventional observational study

Management information
Registered date
2019 Year 05 Month 23 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041933

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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