A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation

A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation - A study of Bortezomib therapy for antibody mediated rejection in kidney transplantation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018628

Enrollment

Registered

2015-10-01

Start date

2015-11-01

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

anti-donor HLA antibody positive recipients for kidney transplantation

Interventions

1.3mg/m2 of Bortezomib would be given on day 1, 4, 8 and 11 by intraveous or subctaneous injection.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Anti-donor HLA antibody positive recipients before and after renal transplantation.

Exclusion criteria

Exclusion criteria: Cardio-respiratory dysfunction, liver dysfunction (AST/ALT>2.5 times of upper limits), bone marrow dysfunction (neotrophil<1000/ul, platelet<75000), allergy of Bortezomib as well as disqualified recipients with the other reasons

Design outcomes

Primary

Measure	Time frame
Reduction of anti-donor HLA antibody 3 and 6 months after Bortezomib administration	—

Secondary

Measure	Time frame
When Bortezomib were given to recipients for antibody mediated rejection, serum creatinine level, proteinuria and histology of graft kidney would be checked.	—

Countries

Japan

Contacts

Public ContactKazuhide Saito

Niigata University Medical and Dental Hospital Division of Urology

kazsaito@med.niigata-u.ac.jp025-227-2289

Outcome results

None listed

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