Safety and Efficacy of Eculizumab to prevent antibody mediated rejection in sensitized kidney transplant recipients from a deceased donor
Phase 2
Recruiting
- Conditions
- kidney transplantRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12612000333819
- Lead Sponsor
- Alexion Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients with stage V chronic kidney disease who will receive a kidney transplant from a deceased donor to whom they are sensitized; able to understand the informed consent form and willing to complly with study procedures.
Exclusion Criteria
Prior treatment with eculizumab; blood type incompatible with donor; 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 biopsy-proven AMR, graft loss, patient death or loss to follow up.[Endpoints will be assessed at week 9 post transplant.];Safety and efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplant will also be evaluated. Evaluation of these endpoints will be assessed by monitoring of all adverse events (including serious adverse events, regular monitoring of blood test results), incidence of clinically significant infection requiring intervention, incidence of biopsy-proven acute cellular rejection and incidence of allograft loss for reasons other than AMR.<br>Commonly reported AEs on this drug include headache, thrombocytopenia, viral infection and more severe infection including sepsis.[Endpoints will be evaluated at week 9 and month 12 post transplantation.]
- 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, day 14, month 3, month 12 and month 36 post transplant]