UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of kidney transplant patients (Japan Academic Consortium of Kidney Transplantation : JACK-II)
Acronym	Japan Academic Consortium of Kidney Transplantation : JACK-II
Scientific Title	Prospective observational study of kidney transplant patients (Japan Academic Consortium of Kidney Transplantation : JACK-II)
Scientific Title:Acronym	Japan Academic Consortium of Kidney Transplantation : JACK-II
Region	Japan

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

Objectives
Narrative objectives1	The aim of this cohort study is to disclose medical examinations to optimize treatment for kidney transplant patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	kidney graft function
Key secondary outcomes	Incidence of rejection, Histopathological findings of kidney grafts, complication, infection, medical cost, graft survival, patient survival, changes of treatment, long and short term outcomes, and so on.

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Kidney transplant recipients and living donors 2.Patients who had a detailed briefing of the trial with explanatory documents prior to the enrollment and voluntarily signed a consent form.
Key exclusion criteria	1.Not-agerrment patients who had a detailed briefing of the trial with explanatory document prior to the enrollment 2.Investigator considered inappropriate as a subject of this study.
Target sample size	1600

Research contact person
Name of lead principal investigator	1st name Kazunari Middle name Last name Tanabe
Organization	Tokyo Women's Medical University
Division name	Urology
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku, Tokyo, Japan
TEL	03-3353-8111
Email	tanabe@twmu.ac.jp

Public contact
Name of contact person	1st name Masayoshi Middle name Last name Okumi
Organization	Tokyo Women's Medical University
Division name	Urology
Zip code	162-8666
Address	8-1 Kawada-cho, Shinjuku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	okumi@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
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)

IRB Contact (For public release)
Organization	Tokyo Women's Medical Univerity
Address	8-1 Kawada-cho, Shinjuku, Tokyo
Tel	03-3353-8111
Email	okumi@twmu.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	東京女子医科大学病院（東京都） 九州大学病院（福岡県） 原三信病院（福岡県） 友愛会豊見城中央病院（沖縄県） 東京女子医科大学八千代医療センター（千葉県） 東光会戸田中央総合病院（埼玉県） 東京都保健医療公社大久保病院（東京都） ときわ会常磐病院（福島県） ときわ会腎移植フォローセンター・余丁町クリニック（東京都） 東京慈恵会医科大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 20 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	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2017 Year 09 Month 05 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry	2027 Year 12 Month 31 Day
Date trial data considered complete	2027 Year 12 Month 31 Day
Date analysis concluded	2027 Year 12 Month 31 Day

Other
Other related information	STATZ Institute. Inc.

Management information
Registered date	2018 Year 07 Month 19 Day
Last modified on	2019 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038143