NCT03221842

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

A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the 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 in Adult Renal Transplant Recipients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Antibody-mediated Rejection

Interventions

Type	Name	Description
DRUG	C1-esterase inhibitor	C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution
DRUG	Placebo	Excipients of C1-INH plus albumin

Timeline

• Start date: 2017-11-06
• Primary completion: 2021-01-20
• Completion: 2021-01-20
• First posted: 2017-07-19
• Last updated: 2022-07-29
• Results posted: 2022-01-18

Locations

26 sites across 7 countries: United States, Belgium, France, Germany, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study