Chronic kidney disease patient to whom ABO incompatibility kidney transplantation is planned.
Conditions
Interventions
IDEC-C2B8 at 375mg/m2/dose will be administrated two times 14 days before and just the day before transplantation.
Sponsors
Zenyaku Kogyo Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of humoral rejection mediated by anti-ABO antibody, which may occur within 4 weeks after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) 1-year graft survival 2) 1-year patient survival 3) 1-year incidence of rejection reaction | — |
Countries
Japan
Contacts
Public ContactMasahiro Abe
Zenyaku Kogyo Co., Ltd. Clinical Operations, Section 1
Outcome results
None listed