UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study using data of kidney transplant patients
Title of the study (Brief title)	Clinical study using data of kidney transplant patients
Region	Japan

Condition
Condition	Kidney transplantation
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore factors which contribute to kidney allograft survival
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Kidney allograft survival rate
Key secondary outcomes	The rate of rejection episodes The occurrence of systemic complications

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	kidney transplant patients
Key exclusion criteria	non kidney transplant patients
Target sample size	100

Research contact person
Name of lead principal investigator	Mototsugu Oya
Organization	Keio University school of medicine
Division name	Urology
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	03-5363-3825
Email	moto-oya@keio.jp

Public contact
Name of contact person	Kazunobu Shinoda
Organization	Keio University School of Medicine
Division name	Urology
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	03-5363-3825
Homepage URL
Email	kshino49@yahoo.co.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 06 Month 21 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Registration is now ongoing. The analysis will be performed.

Management information
Registered date	2017 Year 06 Month 20 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031864