A multi-cohort randomized Phase 2 open-label study to assess the preliminary efficacy safety and pharmacokinetics of BIVV020 for prevention and treatment of antibody-mediated rejection in adult kidney transplant recipients.

Brief description of study

Antibody-mediated rejection (AMR) remains as the most common cause of allograft failure following kidney transplantation. AMR leads to complement-induced inflammation and endothelial injury of the allograft, and there is no approved treatment for prevention or treatment of AMR. Current management of AMR primarily relies on avoiding positive crossmatch transplantation, or utilizing off-label DSA- depleting therapies such as plasmapheresis, intravenous immunoglobulin, and rituximab for pre- and post-transplant desensitization. The purpose of the study is to explore the safety, pharmacokinetics (PK), and efficacy of BIVV020 when given in addition to standard of care (SOC) therapy in renal transplant participants for the prevention and treatment of AMR.

Clinical Study Identifier: s22-00494
ClinicalTrials.gov Identifier: NCT05156710
Principal Investigator: Irfana Soomro.

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