Chronic renal dysfunction or post kidney transplant recipients
Conditions
Interventions
(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
Sponsors
Saito Kazuhide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have anti-donor antibody before or after kidney transplantation
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (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 | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactMasayuki Tasaki
Niigata University Hospital
Outcome results
None listed