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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023787
Receipt No. R000026584
Scientific Title Investigation into the Effectiveness of Allograft Immunocomplex Capture Fluorescence Analysis
Date of disclosure of the study information 2016/10/01
Last modified on 2016/08/27

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Basic information
Public title Investigation into the Effectiveness of Allograft Immunocomplex Capture Fluorescence Analysis
Acronym Graft ICFA
Scientific Title Investigation into the Effectiveness of Allograft Immunocomplex Capture Fluorescence Analysis
Scientific Title:Acronym Graft ICFA
Region
Japan

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

Objectives
Narrative objectives1 Efficacy of graft Immunocomplex Capture Fluorescence Analysis(ICFA) to identify donor specific antibodies in the allografts
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Graft ICFA will be performed at immediate after, within 1 month, 6 months, and 1 year following organ transplantation. Since then, it will be performed annually. On the other hand, in case of graft dysfunction, it will be done properly.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Graft ICFA is performed when a graft (renal, liver) biopsy is required. (no additional procedure will be performed.)
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
0 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Transplantation (renal, liver) recipients who had undergone surgery at our institution, and are required for a graft biopsy.
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Yoshimrua
Organization Kyoto Prefectural University of Medicine
Division name Department of Transplantation and Regenerative Surgery, Graduate School of Medical Science
Zip code
Address Kajii-cho 465, Kamigyo-ku, Kyoto-prefecture, Japan.
TEL 075-251-5532
Email orgtx@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukasa Nakamura
Organization Kyoto Prefectural University of Medicine
Division name Department of Transplantation and Regenerative Surgery, Graduate School of Medical Science
Zip code
Address Kajii-cho 465, Kamigyo-ku, Kyoto-prefecture, Japan.
TEL 075-251-5532
Homepage URL
Email tsukasa@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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
Address
Tel
Email

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
2016 Year 10 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 27 Day
Last modified on
2016 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026584

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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