We are doing this study to see if a drug called eculizumab (not approved for use in transplantation) is a safe and effective treatment for transplant patients who develop antibody mediated rejection (AMR). One of the ways that the body protects itself from infection is with the ability to recognize and destroy foreign material (such as bacterial or viral infections).  In the case of transplantation a person’s body detects recognizes the transplant as foreign, and the body may produce antibodies (specialized proteins) to attack the transplant.  Sometimes, people who receive a kidney transplant have antibodies that attack the new kidney causing it to be rejected by their body.  This is known as AMR. The antibodies can severely damage or even destroy the transplanted kidney.This research study will compare a drug called eculizumab (Solaris), to the usual therapy (called ‘standard of care’ or ‘SOC’), of plasma exchange, that people who develop AMR currently receive at Brigham and Women’s Hospital (BWH).  Each patient participating in this study will be randomized to either the SOC therapy or the infusion drug therapy.  Patients in the SOC therapy arm of the study can receive eculizumab if SOC therapy fails.    The Brigham and Women’s Hospital is the lead site and around 21 subjects, from three different hospitals, will take part in this study over 2 years.

Antibody Mediated Rejection Study

Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation

Principal Investigator

Anil Chandrakar, MD

 

Visit clinicaltrials.gov to learn more about participating in this study.