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Clinical study of Rituximab for inhibition of antibody mediated rejection in ABO-incompatible kidney transplantatio

Phase 3
Conditions
Chronic kidney disease patient to whom ABO incompatibility kidney transplantation is planned.
Registration Number
JPRN-UMIN000006635
Lead Sponsor
Zenyaku Kogyo Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
23
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The incidence of humoral rejection mediated by anti-ABO antibody, which may occur within 4 weeks after transplantation.
Secondary Outcome Measures
NameTimeMethod
1) 1-year graft survival 2) 1-year patient survival 3) 1-year incidence of rejection reaction
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