UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023787 |
|---|---|
| Receipt number | 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 10:52:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tsukasa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026584
