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A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients.

A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients. - A Phased Desensitization Protocol for DSA-positive Patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011914
Enrollment
30
Registered
2013-09-30
Start date
2010-03-25
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

DSA-positive Transplant Patients

Interventions

First, a single dose of rituximab (375 mg/m2 body surface) was administered to the patients. And then, one cycle of bortezomib (1.3 mg/m2, days 1, 4, 8 and 11) was administered to the patients.

Sponsors

Transplantation Surgery, Hiroshima University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: DSA positive patients with MFI values greater than 3,000 by LABScreen Single Antigen test. Patients who are informed of this study and consent to participate it by writing.

Exclusion criteria

Exclusion criteria: Patients with current or recent severe systemic infections requiring treatment (systemic antibiotics, antivirals, or antifungals). Serious diarrhea, active ulcer or uncontrolled diabetes likely to interfere with participation in this clinical study. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Known history of allergy to rituximab or bortezomib. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Female subject is pregnant or breast-feeding. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.

Design outcomes

Primary

MeasureTime frame
Negative conversion rate of cross-match test

Countries

Japan

Contacts

Public ContactKentaro Ide

Hiroshima University Hospital Trasnplantation Surgery

ideken@hiroshima-u.ac.jp082-257-5222

Outcome results

None listed

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