NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180323

Registered date:18/03/2019

Clinical trial of Rituximab for desensitization or antibody mediated rejection therapy in anti-donor HLA antibody positive patients

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedChronic renal dysfunction or post kidney transplant recipients
Date of first enrollment18/03/2019
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)(Study of desensitization therapy before kidney transplantation) Plasma exchange followed by administration of rituximab (375mg/m2). Check the MFI value of anti-donor antibody. 1.If MFI value is less than 3000, another rituximab(375mg/m2) is given and kidney transplantation is performed. 2.If MFI value is more than 3000, kidney transplantation is not performed. However, another rituximab(375mg/m2) is given and check MFI value 4 weeks later. (Study of rejection therapy after kidney transplantation) Plasma exchange followed by administration of rituximab (375mg/m2). Check the MFI value of anti-donor antibody 24 weeks later. Grafted kidney biopsy is performed 24 weeks later too (The time of biopsy could be changed because of clinical situation).

Outcome(s)

Primary Outcome(Study of desensitization therapy before kidney transplantation) MFI value of anti-donor antibody 2 and 8 weeks after rituximab administration (Study of rejection therapy after kidney transplantation) MFI value of anti-donor antibody 24 weeks after rituximab administration
Secondary Outcome(Study of desensitization therapy before kidney transplantation) 1.Achievement of kidney transplantation and MFI value of anti-donor antibody on the day of transplantation 2.Safety evaluation (Study of rejection therapy after kidney transplantation) 1.Change of serum creatinine and proteinuria level, histological evaluation 2.Safety evaluation

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteriaPatients who have anti-donor antibody before or after kidney transplantation
Exclude criteria1.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

Related Information

Contact

Public contact
Name Masayuki Tasaki
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata Niigata Japan 951-851
Telephone +81-25-227-2289
E-mail masa1214@med.niigata-u.ac.jp
Affiliation Niigata University Hospital
Scientific contact
Name Kazuhide Saito
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata Niigata Japan 951-8510
Telephone +81-25-227-2289
E-mail kazsaito@med.niigata-u.ac.jp
Affiliation Niigata University Hospital