JRCT ID: jRCTs031180323
Registered date:18/03/2019
Clinical trial of Rituximab for desensitization or antibody mediated rejection therapy in anti-donor HLA antibody positive patients
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Chronic renal dysfunction or post kidney transplant recipients |
Date of first enrollment | 25/12/2013 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | (Study of desensitization therapy before kidney transplantation) Plasma exchange followed by administration of rituximab (375mg/m2). Check the MFI value of anti-donor antibody. 1.If MFI value is less than 3000, another rituximab(375mg/m2) is given and kidney transplantation is performed. 2.If MFI value is more than 3000, kidney transplantation is not performed. However, another rituximab(375mg/m2) is given and check MFI value 4 weeks later. (Study of rejection therapy after kidney transplantation) Plasma exchange followed by administration of rituximab (375mg/m2). Check the MFI value of anti-donor antibody 24 weeks later. Grafted kidney biopsy is performed 24 weeks later too (The time of biopsy could be changed because of clinical situation). |
Outcome(s)
Primary Outcome | (Study of desensitization therapy before kidney transplantation) MFI value of anti-donor antibody 2 and 8 weeks after rituximab administration (Study of rejection therapy after kidney transplantation) MFI value of anti-donor antibody 24 weeks after rituximab administration |
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Secondary Outcome | (Study of desensitization therapy before kidney transplantation) 1.Achievement of kidney transplantation and MFI value of anti-donor antibody on the day of transplantation 2.Safety evaluation (Study of rejection therapy after kidney transplantation) 1.Change of serum creatinine and proteinuria level, histological evaluation 2.Safety evaluation |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Patients who have anti-donor antibody before or after kidney transplantation |
Exclude criteria | 1.Pregnant, unwilling to practice contraception during the study, or lactating female 2.Decrease in cardiac function or lung function 3.Liver dysfunction (AST or ALT >3.0 x ULN, Total bilirubin > 2.0 mg/dl) 4.Decrease in bone marrow function (Neutrophil < 1500 /microL, platelet less than 100000 /microL, Hb < 8.0 g/dl) 5.Chronic or active infection (HIV or HCV or HTLV1 antibody positive, HBV DNA positive in blood, any infectious condition under Rituximab treatment) 6.Hypersensitivity against rituximab, mannitol, or boron 7.Any reason that are considered to be inadequate to attend this trial |
Related Information
Primary Sponsor | Saito Kazuhide |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Masayuki Tasaki |
Address | 1-754 Asahimachi-dori, Chuo-ku, Niigata Niigata Japan 951-851 |
Telephone | +81-25-227-2289 |
masa1214@med.niigata-u.ac.jp | |
Affiliation | Niigata University Hospital |
Scientific contact | |
Name | Kazuhide Saito |
Address | 1-754 Asahimachi-dori, Chuo-ku, Niigata Niigata Japan 951-8510 |
Telephone | +81-25-227-2289 |
kazsaito@med.niigata-u.ac.jp | |
Affiliation | Niigata University Hospital |