The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation

Inclusion Criteria: * Patient is ≥ 18 years of age. * Patient has a panel reactive antibody (PRA) ≥ 70% at any time prior to screening. * Patient is considered compliant and intends to be available for a minimum follow-up study period of 1 year. * Patient must be vaccinated against Neisseria meningitides at least 2 weeks prior to receiving treatment therapy or receive appropriate antibiotic prophylaxis for the duration of eculizumab treatment if timely vaccination could not be achieved prior to transplantation. * Voluntary written informed consent must be obtained before performance of any study-related procedure not considered routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Female subject is either post-menopausal or surgically sterilized or willing to use two acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for up to 2 months after the last dose of study medication. Exclusion Criteria: * Donor or recipient age is \< 18 years or \> 75 years. * Cold ischemia time is \> 6 hours. * Current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (TB), as determined by local standard of care. * History of active TB within the last 2 years, even if treated. * History of active TB greater than 2 years ago, unless there …