UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018628 |
|---|---|
| Receipt number | R000021557 |
| Scientific Title | A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2017/02/12 09:42:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation
Acronym
A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation
Scientific Title
A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation
Scientific Title:Acronym
A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation
Region
| Japan |
Condition
Condition
anti-donor HLA antibody positive recipients for kidney transplantation
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study about the effects of anti-donor HLA antibody reduction by Bortezomib treatment in renal transplant recipients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Reduction of anti-donor HLA antibody 3 and 6 months after Bortezomib administration
Key secondary outcomes
When Bortezomib were given to recipients for antibody mediated rejection, serum creatinine level, proteinuria and histology of graft kidney would be checked.
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
1.3mg/m2 of Bortezomib would be given on day 1, 4, 8 and 11 by intraveous or subctaneous injection.
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
Anti-donor HLA antibody positive recipients before and after renal transplantation.
Key exclusion criteria
Cardio-respiratory dysfunction, liver dysfunction (AST/ALT>2.5 times of upper limits), bone marrow dysfunction (neotrophil<1000/ul, platelet<75000), allergy of Bortezomib as well as disqualified recipients with the other reasons
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Saito |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Urology
Zip code
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
025-227-2289
kazsaito@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhide Saito |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Urology
Zip code
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
025-227-2289
Homepage URL
kazsaito@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | 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
| 2015 | Year | 08 | Month | 10 | Day |
Last modified on
| 2017 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021557
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/02/12 | 泌尿器 田崎 ベルケイド介入試験計画書(第1版）20151102.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/02/12 | アセントフォーム ベルケイド20151102 (FIX).docx |
| Research case data | |
|---|---|
| Registered date | File name |
