UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011914 |
|---|---|
| Receipt number | R000013914 |
| Scientific Title | A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients. |
| Date of disclosure of the study information | 2013/09/30 |
| Last modified on | 2024/10/07 18:35:37 |
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Basic information
Public title
A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients.
Acronym
A Phased Desensitization Protocol for DSA-positive Patients.
Scientific Title
A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients.
Scientific Title:Acronym
A Phased Desensitization Protocol for DSA-positive Patients.
Region
| Japan |
Condition
Condition
DSA-positive Transplant Patients
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical trial to evaluate efficacy and safety of Rituximab and Bortezomib applied to pre-operative desensitization for prevention or post-operational treatment of antibody-mediated rejection in high risk anti-HLA antibody positive organ transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative conversion rate of cross-match test
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
First, a single dose of rituximab (375 mg/m2 body surface) was administered to the patients. And then, one cycle of bortezomib (1.3 mg/m2, days 1, 4, 8 and 11) was administered to the patients.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DSA positive patients with MFI values greater than 3,000 by LABScreen Single Antigen test.
Patients who are informed of this study and consent to participate it by writing.
Key exclusion criteria
Patients with current or recent severe systemic infections requiring treatment (systemic antibiotics, antivirals, or antifungals).
Serious diarrhea, active ulcer or uncontrolled diabetes likely to interfere with participation in this clinical study.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Known history of allergy to rituximab or bortezomib.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
Female subject is pregnant or breast-feeding.
Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ohdan |
Organization
Hiroshima University Hospital
Division name
Trasnplantation Surgery
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5222
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ide |
Organization
Hiroshima University Hospital
Division name
Trasnplantation Surgery
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5222
Homepage URL
ideken@hiroshima-u.ac.jp
Sponsor or person
Institute
Transplantation Surgery, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hosital
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
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
| 2013 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2013 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013914
