31
Participants
Start Date
March 31, 2008
Primary Completion Date
May 31, 2017
Study Completion Date
August 31, 2017
Eculizumab
"* Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery.~* Patients will be given 900 mg of eculizumab on Day 1 post-transplant.~* Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant~* At week 4, patients will be assessed for B cell flow cytometry cross match (FCXM). Patients with B cell FCXM less than 200 will stop eculizumab treatment. Patients with B cell FCXM greater than or equal to 200 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly. Similar discontinuation assessments will be performed at week 9, 26, 39 and 52.~* In addition, eculizumab 600 mg will be administered immediately after each plasmapheresis (PP) and immediately after any fresh frozen plasma (FFP) that is given post-transplant during the treatment period"
Mayo Clinic, Rochester
Collaborators (1)
Alexion Pharmaceuticals, Inc.
INDUSTRY
Mark Stegall
OTHER