The study of therapy for antibody mediated rejectio
Phase 3
- Conditions
- antibody mediated rejection
- Registration Number
- JPRN-jRCTs051190074
- Lead Sponsor
- obori Shuji
- Brief Summary
o evidence of rejection including antibody mediated rejection was found in all cases. No use of bortezomib or eculizumab in all cases. No complications were observed in all cases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
1. kidney or liver transplantation with ABO incompatible, preexisted DSA or de novo DSA
2. biopsy proven antibody mediated rejection
3. Adequate organ function:
(1) Neutrophil >1,500/mm3
(2) Total bilirubin < 1.5mg/dL (only in kidney transplantation)
(3) AST < 100IU/L (only in kidney transplantation)
(4) ALT < 100IU/L (only in kidney transplantation)
4. Witten informed consent
Exclusion Criteria
1. Active infection
2. Fever more than 38c
3. Active cancer
4. Pregnant, unwilling to practice contraception during the study, or lactating female
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method graft survival, patient survival
- Secondary Outcome Measures
Name Time Method graft function before and after treatment<br> Creatinine (kidney transplantation)<br> AST/ALT, T-Bil (liver transplantation)<br> Pathological findings by biopsy