OPEN LABEL TRIAL OF ECULIZUMAB IN THE PREVENTION OF AMR IN DECEASED DONOR KIDNEY TRANSPLANT SENSITIZED RECIPIENTS
Phase 1
- Conditions
- Antibody mediated rejection after kidney transplantMedDRA version: 16.1Level: LLTClassification code 10064683Term: Antibody-mediated rejectionSystem Organ Class: 100000004870Therapeutic area: Body processes [G] - Integumentary System Physiological Phenomena [G13]
- Registration Number
- EUCTR2010-019631-35-SE
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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
1. Has received treatment with eculizumab at any time prior to enrolling in this study
2. ABO incompatible with deceased donor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.;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
- Secondary Outcome Measures
Name Time Method 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