A Prospective Open Label Randomised Multicentre Study Evaluating the Efficacy & Safety of Rituximab Given Pre-Transplant to Sensitised Renal Allograft Recipients in Addition to a "Standard" Desensitisation Regimen Consisting of PE/IVIG & MMF
This study is designed to investigate in a prospective, randomised fashion whether a single
intravenous dose of rituximab (375 mg/m2) given two weeks prior to transplant, in addition
to standard therapy, will allow sensitised renal transplant subjects to achieve a negative
CDC crossmatch and thereby proceed to live donor transplantation. We will also evaluate
whether rituximab will reduce the number of AAMR episodes in the post-transplant period,
compared to controls. All eligible subjects must have a positive T- and/or B-cell CDC or
flow cytometry crossmatch and have donor-specific antibodies identified by solid-phase assay
at screening. All subjects will receive a standard desensitisation regimen that includes
plasma exchange/IVIG + MMF before and immediately after transplantation followed by a
standard care immunosuppressive regimen (IL-2R antagonist, tacrolimus, mycophenolate mofetil
[MMF] and corticosteroids) after transplantation.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Biopsy proven antibody mediated rejection
12 months
Paul R Trevillian, MBBS, FRACP
Study Chair
Newcastle Transplant Unit, John Hunter Hospital
Australia: Human Research Ethics Committee
RAPTURE
NCT00371904
April 2006
January 2009
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