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

• Status: Completed
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

Summary

All individuals who receive a heart transplant are at risk for developing antibody-mediated rejection (AMR). An antibody is a protein produced by the body's immune system when it detects a foreign substance, called an antigen. The mechanism of an antibody is to attack an antigen. In antibody mediated rejection, antibodies will attack the transplanted heart, causing injury to the heart. The purpose of this investigation is to determine if a study drug, called eculizumab (Soliris), is safe to use in heart transplant recipients, and determine if it reduces risk of antibody-mediated rejection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: Alexion Pharmaceuticals
• Treatments: Antibodies; Eculizumab; Immunoglobulins

Criteria

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of any study-related procedure not considered routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 is documentation of adequate treatment according to locally accepted clinical practice.

(Note: Patients at risk of TB reactivation preclude administration of conventional immunosuppression, as determined by the study investigator and based upon appropriate evaluation).

• Receipt of desensitization treatment with rituximab less than 2 weeks prior to therapy and cluster of differentiation antigen 20 (CD20) count >2%.

• Receipt of a live vaccine within 4 weeks prior to study entry.

• Patients with current or recent severe systemic infections within the 2 weeks prior to transplantation.

• Prior history of splenectomy.