Clinical trial of Rituximab for desensitization or antibody mediated rejection therapy in anti-donor HLA antibody positive patients
Not Applicable
Recruiting
- Conditions
- Chronic renal dysfunction or post kidney transplant recipients
- Registration Number
- JPRN-jRCTs031180323
- Lead Sponsor
- Saito Kazuhide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Patients who have anti-donor antibody before or after kidney transplantation
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (Study of desensitization therapy before kidney transplantation)<br>MFI value of anti-donor antibody 2 and 8 weeks after rituximab administration<br><br>(Study of rejection therapy after kidney transplantation)<br>MFI value of anti-donor antibody 24 weeks after rituximab administration
- Secondary Outcome Measures
Name Time Method (Study of desensitization therapy before kidney transplantation)<br>1.Achievement of kidney transplantation and MFI value of anti-donor antibody on the day of transplantation<br>2.Safety evaluation<br><br>(Study of rejection therapy after kidney transplantation)<br>1.Change of serum creatinine and proteinuria level, histological evaluation<br>2.Safety evaluation