Safety & Efficacy of Eculizumab to Prevent antibody mediated rejection in Living Donor Kidney Transplant Recipients Requiring Desensitizatio
Phase 2
Recruiting
- Conditions
- Kidney transplantRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12611000880943
- Lead Sponsor
- Alexion Pharmaceuticals Australasia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1.Male or female patients >=18 years old
2.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
3.Able to understand the informed consent form and willing to comply with study procedures
Exclusion Criteria
1.Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
2.Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary composite endpoint is the Week 9 post-transplantation treatment failure rate defined as the occurrence of 1) biopsy-proven AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up. The diagnosis of AMR will be based on kidney allograft <br>The primary analysis of all endpoints will occur after all patients have reached Month 12 post-transplantation.[Endpoints will be assessed at week 9 post transplant.]
- Secondary Outcome Measures
Name Time Method Cumulative incidence of AMR occurring between Week 9 and Month 12 post transplant.[Biopsies will be taken post reperfusion, at day 14, months 3 and 12. There will be another biopsy at month 36 post transplantation for long term follow up purposes.]