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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012837
Receipt No. R000014996
Scientific Title Bortezomib administration examination for high sensitization renal transplantation candidates.
Date of disclosure of the study information 2014/01/14
Last modified on 2019/01/17

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Basic information
Public title Bortezomib administration examination for high sensitization renal transplantation candidates.
Acronym Bortezomib for high sensitized renal transplantation.
Scientific Title Bortezomib administration examination for high sensitization renal transplantation candidates.
Scientific Title:Acronym Bortezomib for high sensitized renal transplantation.
Region
Japan

Condition
Condition high sensitized renal transplantation candidates
Classification by specialty
Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 avoiding Antibody mediated rejection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes I perform kidney biopsy after transplant approximately three months later and confirm it pathologically
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.3 mg/m2 bortezomib is administrated by subcutaneous injection after transplant on the POD1, 4, 8, 11.
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
10 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria positive crossmatch
high level of DSA
Key exclusion criteria myelosuppression
inflammatory lung disease
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Miyauchi
Organization Ehime Universoty
Division name Department of Urology
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5356
Email uroyuukictb12@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiro Nakatsuka
Organization Ehime University
Division name Medical department research partnership division
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5172
Homepage URL
Email uroyuukictb12@yahoo.co.jp

Sponsor
Institute Ehime University
Institute
Department

Funding Source
Organization Ehime University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 01 Month 14 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 11 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 13 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014996

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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