drugset / Trial / NCT01106027

Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant

NCT01106027

Phase 1/2 Terminated 2 enrolled Mayo Clinic Alexion Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to test whether a dosing regimen of eculizumab in addition to standard posttransplant care in positive crossmatch deceased donor kidney transplant recipients will reduce the incidence of acute humoral rejection (AHR). Patients included in this study will be those who have demonstrable anti-human leukocyte antigen (HLA) antibody specific for their deceased donor. It is our hypothesis that blockade of terminal complement activation with eculizumab at the time of transplant in combination with our current protocols will reduce the incidence of AHR in recipients of deceased donor kidney transplants who have anti-donor HLA antibody

Timeline

Start
2010-03
Primary completion
2016-08-19
Completion
2016-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody 900 mg Intravenous
Subject Eculizumab Monoclonal antibody 1200 mg Intravenous

Indications

No indication recorded.