Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
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Keep this study
Lead
CSL Behring
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female at least 18 years of age;
Evidence of at least one donor-specific antibody (DSA);
Recipient of a kidney transplant;
Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant in subjects with slow or delayed graft function;
Acute AMR.
You may not be if
Recipient of an en bloc kidney transplant;
Current active hepatitis C virus (HCV) infection;
Active bacterial or fungal infection;
Ongoing dialysis \>2 weeks;
Known congenital bleeding or coagulopathy disorder;
Current cancer or a history of cancer;
Female subjects who are pregnant or breast feeding;
Male or female subjects who are unwilling to use contraception or who are not surgically sterile.
Clareo Health | Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
