The study of therapy for antibody mediated rejection

The study of therapy for antibody mediated rejection in ABO-incompatible, preexisted and de novo donor specific antibody positive kidney and liver transplant patients with rituximab, proteasome inhibitor, complement inhibitor and IVIG - The study of therapy for antibody mediated rejection

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051190074

Enrollment

100

Registered

2019-11-13

Start date

2016-10-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antibody mediated rejection antibody mediated rejection

Interventions

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) preexiste

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
graft survival, patient survival	—

Secondary

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

Contacts

Public ContactShuji Nobori

University Hospital Kyoto Prefectural University of Medicine

snobo@koto.kpu-m.ac.jp+81-75-251-5532

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026