UMIN-CTR Clinical Trial

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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