The novel treatment for post-transplant antibody-mediated rejection.
- Conditions
- 1. Positive of antibody for HLA 2. Antibody-mediated rejection
- Registration Number
- JPRN-jRCTs031180264
- Lead Sponsor
- Egawa Hiroto
- Brief Summary
All patients received rituximab. Safety: No unlisted serious side effects were observed. Efficacy: Sensitized cases before transplantation: The efficacy was showed. (pre-transplant desensitization purpose) The cases with antibody-mediated rejection: The efficacy was suggested. But the efficacy was poor in cases of graft dysfunction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 14
1. Sensitized cases before transplantation: Positive of antibody for HLA and awaiting for the organ transplantation including liver, heart, pancreas/islet or small intestine.
2. The cases with antibody-mediated rejection: With ongoing AMR after organ transplantation including liver, heart, lung, pancreas/islet or small intestine.
3. Under fully informed consent with legal representative.
1. The cases with active infection.
2. The cases with viable malignancy, excluding hepatocellular carcinoma which is rescued by liver transplantation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Sensitized cases before transplantation: the incidence of negativity of anti-HLA antibody, or the change of anti-HLA antibody titer.<br>2. The cases with antibody-mediated rejection: organ function or pathological finding.
- Secondary Outcome Measures
Name Time Method (1)Change of anti-HLA antibody from before and after treatment.<br>(2)The rate of patients occurred antibody-mediated rejection.<br>(3)The rate of patients occurred T cell-mediated rejection.<br>(4)Patients and grafts survival.<br>(5)Evaluation of transplant organ function<br>(6)Adverse events.