UMIN ID: UMIN000000732
Registered date:10/06/2007
Multicenter study of combination therapy using mizoribine, cyclosporin, basiliximab and steroids in kidney transplantation.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Kidney transplantation |
Date of first enrollment | 2006/06/01 |
Target sample size | 70 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | cyclosporinbasiliximab + steroids + mizoribine |
Outcome(s)
Primary Outcome | Incidence of virus infection |
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Secondary Outcome | Rejection reactions (incidence, types, severity), patient survival rate, graft suvival rate, incidence of adverse events / abnormalities in the laboratory values. |
Key inclusion & exclusion criteria
Age minimum | 2years-old |
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Age maximum | 70years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1.The patient who has a history of hypersensitivity against components of either one of the following drugs: Bredinin tablet, Neoral or Simulect. 2.The patient who is pregnant or a female patient who is expecting to become pregnant. 3.The patients who showed a positive result with cross match test. 4.The patient who recived ABO incompatible donor. 5.The patient with whom the physician-in-charge considered inappropriate as a subject of this study. |
Related Information
Primary Sponsor | MNKT Forum |
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Secondary Sponsor | |
Source(s) of Monetary Support | Self funding |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | 03-5919-3825 |
Affiliation | MNKT Forum Keio University Department of Urolgy |
scientific contact | |
Name | Akira Hasegawa |
Address | 6-11-1 Omori-nishi Ota-ku,Tokyo,Japan Japan |
Telephone | |
Affiliation | Toho University School of Medicine |