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

Alexion Pharmaceuticals, Inc.80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stage V Chronic Kidney Disease

Interventions

EculizumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Unnamed facility

Adelaide, Australia

Unnamed facility

Camperdown, Australia

Unnamed facility

Parkville, Australia

Unnamed facility

Bordeaux, France

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 9

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.