NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180264

Registered date:13/03/2019

The novel treatment for post-transplant antibody-mediated rejection.

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studied1. Positive of antibody for HLA 2. Antibody-mediated rejection
Date of first enrollment28/03/2018
Target sample size41
Countries of recruitment
Study typeInterventional
Intervention(s)Rituximab is intravenously administered with single dose of 375 mg/m2.

Outcome(s)

Primary Outcome1. 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.
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 minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. The cases with active infection. 2. The cases with viable malignancy, excluding hepatocellular carcinoma which is rescued by liver transplantation.

Related Information

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
E-mail 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
E-mail egawa.hiroto@twmu.ac.jp
Affiliation Tokyo Women's Medical University Hospital