OPEN LABEL CONTROLLED TRIAL OF ECULIZUMAB IN THE PREVENTION OF AMR IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATIO
Phase 1
- Conditions
- Antibody mediated rejection after kidney transplantMedDRA version: 15.1 Level: LLT Classification code 10064683 Term: Antibody-mediated rejection System Organ Class: 100000004870Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2010-019630-28-GB
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 102
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
- Has received treatment with eculizumab at any time prior to enrolling in this study
- ABO incompatible with living donor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method