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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048077
Receipt No. R000054751
Scientific Title Observational study on kidney prognosis and overall survival in patients after non-renal organ transplantation
Date of disclosure of the study information 2022/06/16
Last modified on 2022/06/16

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Basic information
Public title Observational study on kidney prognosis and overall survival in patients after non-renal organ transplantation
Acronym Observational study on kidney prognosis and overall survival in patients after non-renal organ transplantation
Scientific Title Observational study on kidney prognosis and overall survival in patients after non-renal organ transplantation
Scientific Title:Acronym Observational study on kidney prognosis and overall survival in patients after non-renal organ transplantation
Region
Japan

Condition
Condition Status post non-renal transplantation
Classification by specialty
Medicine in general Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to reveal the characteristics of kidney injury after non-renal transplantation in Japan by analyzing the kidney injury, kidney function, kidney prognosis, and overall survival of patients after non-renal transplantation.
Basic objectives2 Others
Basic objectives -Others Kidney dysfunction, urinalysis results, kidney biopsy findings
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Kidney dysfunction, urinalysis results, kidney biopsy findings
Key secondary outcomes

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 Patients who received non-renal solid organ transplantation between January 1, 2001 and March 31, 2025
Key exclusion criteria Patients who decline to be included in the study
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Nishi
Organization The University of Tokyo Hospital
Division name Division of Nephrology and Endocrinology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email hrnishi-tky@g.ecc.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Nishi
Organization The University of Tokyo Hospital
Division name Division of Nephrology and Endocrinology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email hrnishi-tky@g.ecc.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
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 Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2022 Year 06 Month 16 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
2022 Year 05 Month 19 Day
Date of IRB
2022 Year 05 Month 19 Day
Anticipated trial start date
2022 Year 05 Month 19 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Age, sex, and clinical data including laboratory test results will be obtained from medical records. Pathology specimens will be reviewed. The information obtained will be statistically analyzed to reveal the characteristics of the cohort.

Management information
Registered date
2022 Year 06 Month 16 Day
Last modified on
2022 Year 06 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054751

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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