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

Phase 2

Completed

• Conditions: Stage V Chronic Kidney Disease
• Interventions: Drug: Eculizumab

• Registration Number: NCT01567085
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Primary Objective:

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Study Start: 2012-08-29
• Primary Completion: 2015-06-11
• Study Completion: 2017-05-24
• Results First Submitted: 2018-05-25
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Results First Posted: 2019-05-03
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eculizumab	Eculizumab	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.

Primary Outcome Measures

Name	Time	Method
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation	Baseline, Week 9	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.