UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037672 |
|---|---|
| Receipt number | R000042958 |
| Scientific Title | Association of BK polyomavirus antibody titer with BK polyomavirus infection after kidney transplantation |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2019/08/13 10:44:27 |
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Basic information
Public title
Association of BK polyomavirus antibody titer with BK polyomavirus infection after kidney transplantation
Acronym
Association of BK polyomavirus antibody titer with BK polyomavirus infection after kidney transplantation
Scientific Title
Association of BK polyomavirus antibody titer with BK polyomavirus infection after kidney transplantation
Scientific Title:Acronym
Association of BK polyomavirus antibody titer with BK polyomavirus infection after kidney transplantation
Region
| Japan |
Condition
Condition
kidney transplant recipients and donors
Classification by specialty
| Nephrology | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of donor and recipient BKV antibody status with the incidence of post-transplant BKV viremia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of post-transplant BKV viremia
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The donors and the recipients who received living-donor kidney transplantation at Kyushu University Hospital.
Key exclusion criteria
Patients whose ASA physical status was >=4 or who were deemed inappropriate.
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nakamura |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5441
mnaka@surg1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Hisadome |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5441
Homepage URL
hisadome@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)
Name of secondary funder(s)
Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)
IRB Contact (For public release)
Organization
Kyushu University Institutional Review Board for Clinical Research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5774
bynintei@jimu.kyushu-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
| 2019 | Year | 08 | Month | 13 | 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
94
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
| 2014 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The donor-recipient pairs who received living-donor kidneytransplantation were prospectively enrolled in this study between December 2014 and January 2016.
This study investigated the association of pre-transplant donor and recipient BKV antibody status with the occurrence of post-transplant BKV infection.
Management information
Registered date
| 2019 | Year | 08 | Month | 13 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042958
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
