UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034082 |
|---|---|
| Receipt number | R000038857 |
| Scientific Title | Clinical study to evaluate the usefulness of urine heat shock protein 90 as a biomarker for acute allograft rejection after kidney transplantation |
| Date of disclosure of the study information | 2018/09/10 |
| Last modified on | 2026/09/16 11:25:31 |
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Basic information
Public title
Clinical study to evaluate the usefulness of urine heat shock protein 90 as a biomarker for acute allograft rejection after kidney transplantation
Acronym
Urine heat shock protein 90 as a biomarker for acute allograft rejection after kidney transplantation
Scientific Title
Clinical study to evaluate the usefulness of urine heat shock protein 90 as a biomarker for acute allograft rejection after kidney transplantation
Scientific Title:Acronym
Urine heat shock protein 90 as a biomarker for acute allograft rejection after kidney transplantation
Region
| Japan |
Condition
Condition
Chronic kidney disease post kidney transplantation
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of urine heat shock protein 90 concentration as a biomarker for acute allograft rejection after kidney transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationships between urine HSP90 concentration and clinical findings including histological finding on graft biopsy and clinical variables at 2 weeks, 1, 3, 6 and 12 months after kidney transplantation.
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 underwent kidney transplantation.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
060-8543
Address
South-1, West-16, Chuo-ku, Sapporo
TEL
011-611-2111
zappa@pop12.odn.ne.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
0608543
Address
South-1, West-16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
zappa@pop12.odn.ne.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University Schoo; of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI (Grants-in-Aid for Scientific Research)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Sapporo Medical University Hosopital
Address
South-1, West-16, Chuo-ku, Sapporo
Tel
011-611-2111
ji-rskk@sapmed.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
| 2018 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1355814526000672
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1355814526000672
Number of participants that the trial has enrolled
112
Results
Urine HSP90/Cr levels were significantly elevated in acute T cell mediated rejection (ATCMR), although they were not specific to ATCMR.
Results date posted
| 2026 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 08 | Month | 26 | Day |
Baseline Characteristics
Patients who underwent kidney transplantation at Sapporo Medical University Hospital.
Participant flow
Kidney allograft recipients who were scheduled to undergo graft biopsy were enrolled in this study after providing written informed consent.
Adverse events
Nothin was observed.
Outcome measures
Urine and serum HSP90 concentrations, urine and serum creatinine, urine NAG and beta 2-microglobulin, histological examination and immunohistochemical staining for HSP90 in the graft tissue
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results have been published.
Management information
Registered date
| 2018 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038857
