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 (1, 2). The primary mechanism of AMR involves activation of the classical complement pathway (CP) through the interaction of donor-specific antibodies (DSA), pre-existing or de novo, against antigens on the donor organ, leading to complement-induced inflammation and endothelial injury of the allograft (3, 4). There is currently 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 (PP), intravenous immunoglobulin (IVIg), and rituximab for pre- or post-transplant desensitization (5, 6). This study is designed 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.
Other Investigators: Rebecca Anne Esker, Aprajita Mattoo, Bruce E Gelb, Elaina Weldon, Nicole M Ali, Kathryn Sterling Dzurilla, Bonnie Elizabeth Lonze.


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