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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006635
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Zenyaku Kogyo Co., Ltd.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007847

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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