Overview

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that consent may be withdrawn by the subject at any time without prejudice to future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.