UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006635 |
|---|---|
| Receipt number | R000007847 |
| Scientific Title | Clinical study of Rituximab for inhibition of antibody mediated rejection in ABO-incompatible kidney transplantation |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2014/10/27 12:49:33 |
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Basic information
Public title
Clinical study of Rituximab for inhibition of antibody mediated rejection in ABO-incompatible kidney transplantation
Acronym
Clinical study of Rituximab in ABO-incompatible kidney transplantation
Scientific Title
Clinical study of Rituximab for inhibition of antibody mediated rejection in ABO-incompatible kidney transplantation
Scientific Title:Acronym
Clinical study of Rituximab in ABO-incompatible kidney transplantation
Region
| Japan |
Condition
Condition
Chronic kidney disease patient to whom ABO incompatibility kidney transplantation is planned.
Classification by specialty
| Surgery in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The acceptability of efficacy and safety of IDEC-C2B8 as pre-transplant conditioning for inhibition of acute humoral rejection mediated by anti-A or -B andtibody in ABO incompatible kidney transplantation without splenectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The incidence of humoral rejection mediated by anti-ABO antibody, which may occur within 4 weeks after transplantation.
Key secondary outcomes
1) 1-year graft survival
2) 1-year patient survival
3) 1-year incidence of rejection reaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
IDEC-C2B8 at 375mg/m2/dose will be administrated two times 14 days before and just the day before transplantation.
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
| 16 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) subjects with end-stage chronic kidney desease
2) kidney transplantation for the first time
3) 16-74 years of age
4) adequate organ function other than kidney
5) must give written informed consent prior to the study
Key exclusion criteria
1) pregnant woman or lactating mothers
2) positive HBV serology(i.e., HBs antigen, HBs and/or HBc antibody), and positive HCV antibody
3) HIV infection
4) HTLV-1 infection
5) active infection of any kind
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kota Takahashi |
Organization
Niigata University Medical & Dental Hospital
Division name
Division of Urology
Zip code
Address
Asahimachi 1-757, Chuo-ku, Niigata, Japan
TEL
025-227-2407
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Abe |
Organization
Zenyaku Kogyo Co., Ltd.
Division name
Clinical Operations, Section 1
Zip code
Address
6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo
TEL
03-3946-1113
Homepage URL
Sponsor or person
Institute
Zenyaku Kogyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Zenyaku Kogyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
| 2011 | Year | 10 | Month | 31 | Day |
Last modified on
| 2014 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007847
