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
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
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
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
