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The effect of rituximab in desensitization of preoperative DSA positive patients and postoperative ABMR treatment of DSA positive patients in kidney transplantation

The effect of rituximab in desensitization of preoperative DSA positive patients and postoperative ABMR treatment of DSA positive patients in kidney transplantation - The effect of rituximab in DSA positive kidney transplant recipients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035338
Enrollment
10
Registered
2018-12-21
Start date
2013-12-25
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

Chronic renal failure

Interventions

Preoperaive desensitization for DSA positive patients:After informed consent, patient will be evaluated for adaquacy and recieve the antibody removal by plasmapheresis followed by the first dose of ri

Sponsors

Niigata University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients whose pre-kidney transplant lymphocyte crossmatch test were positive(DSA positive) and whose crossmatch test turned positive after kidney transplantation with ABMR. Both gender of patients are acceptable without pregnant and/or possible-pregnant women. Participant age is not limited. All the participants must received written informed consents.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients with cardiac, pulmonary and hepaic dysfunction and severe bone marrow suppression must be excluded. Hypersensitivity history against rituximab and/or boron, who cannot receive informed consent are also excluded. Patients whomDoctor in charge decided inadequate for participate in this study are excluded. Criteria in which study must be stopped: If the participant would expressed refusal against the study. If the study must be stopped due to the severe adveresed event and/or other reaseons for contraindication for treatment and/or kidney transplantation. If this study itself must be stopped according to the certain reason.

Design outcomes

Primary

MeasureTime frame
Primary endpoint of desensitization: Attenuation of DSA-MFI(Mean fluorescent intensity) 2 and 4 weeks after rituximab administration. Primary endpoint of treatment: Attenuation of DSA-MFI 12 and 24 weeks after rituximab administration

Secondary

MeasureTime frame
Secondary endpoint of desensitization: Lymphocyte crossmatch test 2 weeks after rituximab administration and possibility of kidney transplant. Secondary endpoint of treatment: The change of serum Cr.,urinary protein/Cr.ratio, and graft kidney histopathological findings( according to Banff classification)

Countries

Japan

Contacts

Public ContactKazuhide Saito

Niigata University Division of Urology

kazsaito@med.niigata-u.ac.jp+81-25-227-2289

Outcome results

None listed

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