Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

May 31, 2017

Study Completion Date

August 31, 2017

Conditions
Kidney Transplant
Interventions
DRUG

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"

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors
All Listed Sponsors
collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

lead

Mark Stegall

OTHER