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

CSL Behring

Status and phase: Terminated; Phase 3

Conditions: Antibody-mediated Rejection

Treatments: Drug: Placebo; Drug: C1-esterase inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03221842

2017-000348-17 (EudraCT Number)

CSL842_3001

Details and patient eligibility

About

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).

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups, including a placebo group

C1-INH

Experimental group

Description:

C1-esterase inhibitor

Treatment:

Drug: C1-esterase inhibitor

Placebo

Placebo Comparator group

Description:

Excipients of C1-INH plus albumin

Treatment:

Drug: Placebo