UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033449
Receipt number 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 20:55:04

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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 or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



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

Value
https://center6.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