The study of therapy for antibody mediated rejection

JRCT ID: jRCTs051190074

Registered date:13/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: antibody mediated rejection
• Date of first enrollment: 12/10/2016
• Target sample size: 100
• Study type: Interventional

Intervention(s)

infuion of rituximab to all patients with antibody mediated rejection
infusion of bortezomib, eculizumab and IVIG to refractory cases against rituximab
1. rituximab 375mg/m2 (standard dose)
preexisted DSA case:1 or 2 infusion during the period from 4 weeks before to the day before operation
postoperative case:1 or 2 infusion within 2 weeks after diagnosis
2. bortezomib 1.3mg/m2 (standard dose)
preexisted DSA case:1 or 2 infusion during the period from 4 weeks before to the day before operation
postoperative case:1 or 2 infusion within 2 weeks after diagnosis
3. eculizumab 1200mg/day (standard dose)
preexisted DSA case:1 infusion per week during the period from 4 weeks before to the day before operation
postoperative case: 4 weeks once per week after diagnosis
4. IVIG 4g/kg/day (standard dose)
preexisted DSA case: daily infusion during the period from 1 week before to 1 week after operation
postoperative case: daily infusion for a week after diagnosis

Outcome(s)

• Primary Outcome: graft survival, patient survival

Secondary Outcome

graft function before and after treatment
Creatinine (kidney transplantation)
AST/ALT, T-Bil (liver transplantation)
Pathological findings by biopsy

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

1. Active infection
2. Fever more than 38c
3. Active cancer
4. Pregnant, unwilling to practice contraception during the study, or lactating female

Related Information

• Primary Sponsor: Nobori Shuji