Cinryze In Antibody Mediated Kidney Rejection

Brief Description Of Study

To evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free intravenous immunoglobulin (IVIg) for the treatment of acute antibodymediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.Since AMR results in complement-mediated damage to a transplant, the sponsor hypothesized that a complement inhibitor such as plasma-derived C1 inhibitor (C1 INH) could effectively protect a renal allograft while reduction of DSA is achieved with standard-of-care plasmapheresis, plasma exchange, or immune adsorption treatments with sucrose-free IVIg, resulting in less long-term damage to the kidney and prolonged graft survival.

Clinical Study Identifier: 02547220

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