JRCT ID: jRCTs031180264
Registered date:13/03/2019
The novel treatment for post-transplant antibody-mediated rejection.
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | 1. Positive of antibody for HLA 2. Antibody-mediated rejection |
Date of first enrollment | 28/03/2018 |
Target sample size | 41 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Rituximab is intravenously administered with single dose of 375 mg/m2. |
Outcome(s)
Primary Outcome | 1. Sensitized cases before transplantation: the incidence of negativity of anti-HLA antibody, or the change of anti-HLA antibody titer. 2. The cases with antibody-mediated rejection: organ function or pathological finding. |
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Secondary Outcome | (1)Change of anti-HLA antibody from before and after treatment. (2)The rate of patients occurred antibody-mediated rejection. (3)The rate of patients occurred T cell-mediated rejection. (4)Patients and grafts survival. (5)Evaluation of transplant organ function (6)Adverse events. |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 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. |
Exclude criteria | 1. The cases with active infection. 2. The cases with viable malignancy, excluding hepatocellular carcinoma which is rescued by liver transplantation. |
Related Information
Primary Sponsor | Egawa Hiroto |
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Secondary Sponsor | Japan agency for medical research and development |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000031863 |
Contact
Public contact | |
Name | Hiroto Egawa |
Address | 8-1,Kawada-cho,Shinjuku-ku,Tokyo,162-8666,Japan Tokyo Japan 162-8666 |
Telephone | +81-3-3353-8111 |
egawa.hiroto@twmu.ac.jp | |
Affiliation | Tokyo Women's Medical University Hospital |
Scientific contact | |
Name | Hiroto Egawa |
Address | 8-1,Kawada-cho,Shinjuku-ku,Tokyo,162-8666,Japan Tokyo Japan 162-8666 |
Telephone | +81-3-3353-8111 |
egawa.hiroto@twmu.ac.jp | |
Affiliation | Tokyo Women's Medical University Hospital |