UMIN-CTR Clinical Trial

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
Email	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
Email	hisadome@surg1.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042958