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
Purpose
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).
Condition
- Antibody-mediated Rejection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Randomized-withdrawal
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental C1-INH |
C1-esterase inhibitor |
|
|
Placebo Comparator Placebo |
Excipients of C1-INH plus albumin |
|
More Details
- Status
- Terminated
- Sponsor
- CSL Behring