A RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL TO DETERMINE SAFETY AND EFFICACY OF ECULIZUMAB IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION (AMR) IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATION THERAPY
Phase 2
Completed
- Conditions
- antibody mediated rejection after kidney transplant10027665Kidney transplant rejection10029149
- Registration Number
- NL-OMON39259
- Lead Sponsor
- Alexion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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.
Exclusion Criteria
- Has received treatment with eculizumab at any time prior to enrolling in this study;
- ABO incompatible with living donor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and potential efficacy of eculizumab to prevent AMR in<br /><br>sensitized recipients of living donor kidney transplants requiring<br /><br>desensitization therapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>Cumulative incidence of AMR that occurs between Week 9 and Month 12<br /><br>post-transplantation</p><br>