A Randomized, Open-label, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Living Donor Kidney Transplant Recipients Requiring Desensitization Therapy

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The purpose of this trial is to determine the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy.

Who is eligible to participate?

Inclusion Criteria: 1. Male or female patients ≥18 years old 2. Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation 3. Able to understand the informed consent form and willing to comply with study procedures Exclusion Criteria: 1. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients 2. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient

Last updated:

9/3/2014

NCT ID:

NCT01399593

IRB Number:

11-004539