The Impact of Velcade(TM)on Antibody Secreting Cells in Sensitized Renal Allograft Candidates
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Impact of Velcade(TM)on Antibody Secreting Cells in Sensitized Renal Allograft Candidates|
- A 50% reduction in anti-HLA antibody production by bone marrow derived ASC isolated from sensitized renal allograft candidates treated with bortezomib monotherapy in vivo. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
A minimum of four, four-dose cycles (16 doses) and up to eight, four-dose cycles(32 doses) of Velcade(TM) as an intravenous infusion (IV) (through a vein).
Other Name: Velcade(TM)
The study is designed to assess the impact of in vivo treatment of bortezomib on anti-HLA production by normal antibody secreting cells (ASC) in sensitized renal allograft candidates. The design involves in vivo treatment with bortezomib for one 4 dose cycle (days 1, 4, 8 and 11). Using novel assays, anti-HLA production is determined by 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.