Conditions: Kidney Transplantation
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: no

Brief summary:
Patients planning to have kidney transplantation who are sensitized to their donors have high levels of donor specific alloantibodies. High levels of donor specific antibodies put kidney transplant recipients at risk for rejection very early after transplant. This study is trying to determine if the drug bortezomib (Velcade ™) can reduce donor specific alloantibodies to a level that permits kidney transplantation without a high risk for rejection.

Detailed description:
The study is designed to assess the impact of in vivo treatment of bortezomib on anti-human leukocyte antigen (HLA) production by normal antibody secreting cells (ASC) in sensitized renal allograft candidates. The design involves treatment of subjects with bortezomib using one of three dosing regimens (4 doses, 16 doses or 32 doses of bortezomib). Using novel assays, anti-HLA production is determined by measuring the bone marrow derived ASC at baseline (prior to therapy) and after treatment (at day 14, 3 days after the last bortezomib dose). Paired data are used with patients serving as their own controls. Finally, the safety of bortezomib is evaluated by monitoring total serum antibody levels and the incidence of side effects (primarily neuropathy) at 1 month, the final follow-up point.

Arms:
arm 1: 4 doses of bortezomib (1.3mg/m\^2 of body surface area) arm 2: 16 doses of bortezomib (1.3mg/m\^2 of body surface area) arm 3: 32 doses of bortezomib (1.3mg/m\^2 of body surface area)

Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Velcade given in four-dose cycles intravenously (through a vein).

Protocol document: