Eculizumab - The DUET Cardiac Trial

Condition/Intervention:

  • Heart transplant

Study Name:

The De-novo Use of Eculizumab Alongside Conventional Therapy in Presensitized Patients Receiving Cardiac Transplantation: An Open-Label, Investigator-Initiated Pilot Trial (The DUET Cardiac Trial)

Phase:

Pilot

Summary:

The purpose of this research is to determine the safety and efficacy of the investigational use of a drug called eculizumab to prevent antibody-mediated rejection (AMR). Patients who have a heart transplant are at risk for developing AMR, a condition in which antibodies attack the transplanted heart and cause injury to the heart.

Eculizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria. However, it is not yet approved by the FDA for preventing AMR.

Key Inclusion Criteria:

  • At least 18 years of age
  • Has a panel reactive antibody greater than or equal to 70 percent at any time prior to screening
  • Available for a minimum follow-up study period of one year
  • Must be vaccinated against Neisseria meningitides at least two weeks prior to receiving treatment therapy

Key Exclusion Criteria:

  • Donor or recipient age is less than 18 years or greater than 75 years.
  • Cold ischemia time is greater than six hours
  • At risk for tuberculosis
  • Receipt of desensitization treatment with rituximab less than two weeks prior to therapy and CD20 count greater than two percent

Please see complete list of inclusion and exclusion criteria.

Principal Investigator:

Jignesh Patel, MD, PhD

Co-Investigators Include:

Jon Kobashigawa, MD
Michelle Kittleson, MD, PhD
Lawrence Czer, MD

Study Coordinators and Contacts:

Lucilla Garcia
Phone: 310-248-7134
Email: lucilla.garcia@cshs.org

Sean Sana
Phone: 310-248-7129
Email: sean.sana@cshs.org

Status:

Active

IRB No.:

28970

Date Last Updated:

06/15