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) studied | Chronic kidney disease patient to whom ABO incompatibility kidney transplantation is planned. |
| Date of first enrollment | 2011/12/01 |
| Target sample size | 23 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | IDEC-C2B8 at 375mg/m2/dose will be administrated two times 14 days before and just the day before transplantation. |
Outcome(s)
| Primary Outcome | The incidence of humoral rejection mediated by anti-ABO antibody, which may occur within 4 weeks after transplantation. |
|---|---|
| Secondary Outcome | 1) 1-year graft survival 2) 1-year patient survival 3) 1-year incidence of rejection reaction |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 74years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Zenyaku Kogyo Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Zenyaku Kogyo Co., Ltd. |
| Secondary ID(s) |
Contact
| 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 |