Antibody mediated rejection after kidney transplant MedDRA version: 14.1 Level: LLT Classification code 10064683 Term: Antibody-mediated rejection System Organ Class: 100000004870
Conditions
Sponsors
Alexion Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients = 18 years old 2. Patients with Stage V chronic kidney disease who will receive a kidney transplant from a deceased donor to whom they are sensitized 3. Patients must be able to understand the informed consent form and willing to comply with study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Has received treatment with eculizumab at any time prior to enrolling in this study 2. ABO incompatible with deceased donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Safety and efficacy;Primary end point(s): To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.;Timepoint(s) of evaluation of this end point: 9 weeks;Main Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cumulative incidence of AMR between Week 9 and Month 12 post-transplantation;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Australia, Italy, Spain, Sweden, United Kingdom
Contacts
Public ContactEuropean Clinical Trial Information
ALEXION EUROPE SAS
Outcome results
None listed