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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.