Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

• Status: Completed
• Trial end date: 2017-05-24
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Treatments: Eculizumab

Criteria

Inclusion Criteria:

1. Male or female participants ≥18 years old.

2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.

3. History of prior exposure to HLA (human leukocyte antigen):

• Prior solid organ or tissue allograft

• Pregnancy

• Blood transfusion

• Prior exposure to specific donor's HLA

Exclusion Criteria:

1. Has received treatment with eculizumab at any time prior to enrolling in this study.

2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.

3. History of severe cardiac disease.

4. Prior splenectomy.