NIPH Clinical Trials Search

UMIN ID: UMIN000006635

Registered date:01/11/2011

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedChronic kidney disease patient to whom ABO incompatibility kidney transplantation is planned.
Date of first enrollment2011/12/01
Target sample size23
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)IDEC-C2B8 at 375mg/m2/dose will be administrated two times 14 days before and just the day before transplantation.


Primary OutcomeThe incidence of humoral rejection mediated by anti-ABO antibody, which may occur within 4 weeks after transplantation.
Secondary Outcome1) 1-year graft survival 2) 1-year patient survival 3) 1-year incidence of rejection reaction

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum74years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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

Related Information


public contact
Name Masahiro Abe
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo Japan
Telephone 03-3946-1113
Affiliation Zenyaku Kogyo Co., Ltd. Clinical Operations, Section 1
scientific contact
Name Kota Takahashi
Address Asahimachi 1-757, Chuo-ku, Niigata, Japan Japan
Telephone 025-227-2407
Affiliation Niigata University Medical & Dental Hospital Division of Urology