UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048077 |
|---|---|
| Receipt number | 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 19:02:30 |
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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
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
hrnishi-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054751
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
