None listed
Conditions
Brief summary
Antibody mediated rejection post kidney transplant has become a significant clinical problem given that over 25% of kidney transplant candidates have antibodies to potential organ donors. There is no approved treatment for AMR and options to treat are limited. It is hoped that eculizumab will reduce the incidence of AMR post kidney transplantation in sensitized patients.
Interventions
Patients will be randomised to standard of care or eculizumab.
Eculizumab will be administered by IV infusion over 45 minutes. There will be 9 doses of eculizumab over 9 weeks, with 1200mg intravenously just before transplant surgery, followed by 900mg dosed weekly for 4 weeks, then 1200mg administered fortnightly for 6 weeks.
Standard of Care: No Intervention. Patients will receive prophylactic therapy for AMR according to the hospital standard procedure post transplant.
Sponsors
Alexion Pharmaceuticals Australasia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed