UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008475 |
|---|---|
| Receipt number | R000009951 |
| Scientific Title | The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors. |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2022/01/26 11:19:38 |
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Basic information
Public title
The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Acronym
The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Scientific Title
The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Scientific Title:Acronym
The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Region
| Japan |
Condition
Condition
kidney transplant recipients and donors
Classification by specialty
| Nephrology | Surgery in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between histological injuries in renal transplant biopsy and clinical course of the recipients and donors.
Basic objectives2
Others
Basic objectives -Others
retrospective observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
progression to end-stage renal disease or deterioration of renal function
Key secondary outcomes
mortality, rejection, infection, changes in estiamated glomeular filtration rate, cardiovascular event, malignancy, diastolic ventricular dysfunction, vascular calcification, post-transplant anemia, parathyroid function
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
The donors and the recipients who underwent kidney transplantation at Kyushu universtity
from January 1, 2000 to June 25, 2012.
Key exclusion criteria
Patients who wish to not participate in the study or patients who were deemed inappropriate.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Nakano |
Organization
Graduate school of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+81-92-642-5843
nakano.toshiaki.455@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Matsukuma |
Organization
Graduate school of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+81-92-642-5843
Homepage URL
http://www.kcu.med.kyushu-u.ac.jp/index.html
matsukuma.yuta.191@m.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate school of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Graduate school of Medical Sciences, Kyushu University
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
Kyushu University, Department of Clinical Medicine and Science
Address
3-1-1, Maidashi, HIgashi-ku
Tel
092-642-5843
matsukuma.yuta.191@m.kyushu-u.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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.kcu.med.kyushu-u.ac.jp/index.html
Publication of results
Partially published
Result
URL related to results and publications
http://www.kcu.med.kyushu-u.ac.jp/index.html
Number of participants that the trial has enrolled
600
Results
Post-tranplant anemia was associated with interstitial fibrosis in donor kidney
Results date posted
| 2022 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2013 | Year | 09 | Month | 21 | Day |
Baseline Characteristics
Kidney transplant recipient
Participant flow
Obseervational study
Adverse events
None
Outcome measures
Anemia was related with renal fibrosis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
retrospective observational study
Management information
Registered date
| 2012 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009951
| Research Plan | |
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| Registered date | File name |
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