drugset / Trial / 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

NCT03221842

Phase 3 Terminated 63 enrolled CSL Behring
RandomizedSequentialQuadruple-blindTreatment

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).

Timeline

Start
2017-11-06
Primary completion
2021-01-20
Completion
2021-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic

Indications