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

• Status: Terminated
• Trial end date: 2021-01-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Treatments: Antibodies; Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s; Immunoglobulins

Criteria

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.