Cinryze is a plasma-derived C1 esterase inhibitor product that has been approved by the US FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema.
The randomised, double blind, placebo-controlled study will evaluate the safety, tolerability and clinical effect of Cinryze for the treatment of acute antibody-mediated rejection in recipients of donor-specific cross-match positive kidney transplants.
The study will enroll 20 subjects who will be randomised to receive either Cinryze or a placebo, and will be conducted at four transplant centres in the US.
Subjects will be evaluated after eight weeks of treatment for pharmacokinetics, pharmacodynamics and clinical effect, and again at six months post-transplantation for graft function and patient survival.