UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036087 |
|---|---|
| Receipt number | R000012565 |
| Scientific Title | Retrospective analysis of factors influencing long term outcome of kidney transplantation |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2019/03/05 13:32:44 |
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Basic information
Public title
Retrospective analysis of factors influencing long term outcome of kidney transplantation
Acronym
Retrospective analysis of factors influencing long term outcome of kidney transplantation
Scientific Title
Retrospective analysis of factors influencing long term outcome of kidney transplantation
Scientific Title:Acronym
Retrospective analysis of factors influencing long term outcome of kidney transplantation
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factors which influence the longterm outcome of kidney transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient survival and kidney graft survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
kidney transplant patients who were performed one-year protocol kidney graft biopsy
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Takahara |
Organization
Osaka University
Division name
Advanced Technology for Transplantation
Zip code
Address
2-2, J8, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3746
takahara@att.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotsugu Ichimaru |
Organization
Osaka University
Division name
Advanced Technology for Transplantation
Zip code
Address
2-2, J8, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3746
Homepage URL
ichimaru@att.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Advanced Technology for Transplantation, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ten-year kidney graft survival was significantly deteriorated in de novo DSA-positive at the first year after kidney transplantation cases.
Management information
Registered date
| 2019 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012565
