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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034082
Receipt No. 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 2020/09/14

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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
Email 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
Email zappa@pop12.odn.ne.jp

Sponsor
Institute Department of Urology, Sapporo Medical University Schoo; of Medicine
Institute
Department

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
Email 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
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 Open public recruiting
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 18 participants have been registered.

Management information
Registered date
2018 Year 09 Month 10 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038857

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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