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

PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

December 30, 2019

Study Completion Date

April 30, 2020

Conditions
Antibody-mediated RejectionHyperacute Rejection of Cardiac TransplantLeft Ventricular DysfunctionCardiac Allograft VasculopathyHeart Graft Dysfunction
Interventions
DRUG

Eculizumab

"At the time of transplantation, 1200mg of Eculizumab will be administered via a 35 minute IV infusion, followed by thymoglobulin 1.5 mg/kg intravenous piggyback (IVPB). The administration of thymoglobulin will be repeated (if blood counts permit) for a total of five doses.~On Day 1 post-transplant, 900 mg of Eculizumab will be given via an IV infusion.~On Day 5 post-transplant, intravenous immunoglobulin (IVIG) 1 gram/kg will be administered daily for two consecutive days.~On post-transplant days 7, 14, and 21 (+/- 2 days) 900mg of Eculizumab will be given via an IV infusion at each scheduled visit.~On post-transplant days 28, 42, and 56 (+/- 2 days) 1200 mg of Eculizumab will be given via an IV infusion at each scheduled visit."

Trial Locations (1)

90048

Cedars Sinai Medical Center, Heart Institute, Los Angeles

Sponsors
All Listed Sponsors
collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

lead

Cedars-Sinai Medical Center

OTHER