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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Status post non-renal transplantation | ||
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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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 |
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Last modified on |
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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 |