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

Study Overview
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Brief Summary
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Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

Official Title
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An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor.

Conditions
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Stage V Chronic Kidney Disease

Intervention / Treatment
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* Drug: Eculizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants ≥18 years old. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized. 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: Has received treatment with eculizumab at any time prior to enrolling in this study. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor. History of severe cardiac disease. Prior splenectomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eculizumab<br>Eculizumab 1200 milligrams (mg) was administered intravenously (IV) over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days. | Drug: Eculizumab<br> <br> * Other names: Soliris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation | Results are reported for post-transplantation treatment failure and composite endpoints, defined as the occurrence of biopsy-proven acute antibody-mediated rejection (AMR), graft loss, death, or loss to follow-up (including discontinuation) in the first 9 weeks post transplantation. The diagnosis of acute AMR (occurring within the first 9 weeks post transplantation) was based on kidney allograft dysfunction and a biopsy performed due to suspected rejection, proteinuria, increased serum creatinine, or acute tubular necrosis. Treatment failure was the occurrence of at least 1 of the composite endpoint components by Week 9 post transplantation. A participant experiencing multiple events was only counted once for the composite endpoint. | Baseline, Week 9 |