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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033449
Receipt No. R000038143
Scientific Title Prospective observational study of kidney transplant patients (Japan Academic Consortium of Kidney Transplantation : JACK-II)
Date of disclosure of the study information 2018/07/20
Last modified on 2019/07/22

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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/ctr_e/ctr_view.cgi?recptno=R000038143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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