Antibody mediated rejection after kidney transplant MedDRA version: 15.1 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: - Male or female patients = 18 years old - Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation - Patients must be willing and able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 89 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Has received treatment with eculizumab at any time prior to enrolling in this study - ABO incompatible with living donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy prior to transplantation;Secondary Objective: Safety and Efficacy;Primary end point(s): To evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.;Timepoint(s) of evaluation of this end point: 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cumulative incidence of AMR that occur between week 9 and month 12 post-transplantation.;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Australia, Canada, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactEuropean Clinical Trial Information
ALEXION EUROPE SAS
Outcome results
None listed