Chronic renal failure
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Niigata University Division of Urology