Overview

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Status:
Terminated

Trial end date:
2015-11-13

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Alexion Pharmaceuticals

Treatments:

Eculizumab

Criteria

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

Exclusion Criteria:

1. ABO incompatible with living donor

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