Imlifidase efficacy and safety
1 evidence topic · 4 sources
Summary
ConfIdeS was an open-label, randomized, controlled phase 3 trial involving 64 participants with cPRA of at least 99.9%. The sponsor reported mean eGFR at 12 months of 51.5 mL/min/1.73 m² with imlifidase and 19.3 mL/min/1.73 m² in the control arm, with p<0.0001. A subsequent sponsor presentation reported antibody-mediated rejection in 16 of 28 participants in the imlifidase arm and 6 of 13 in the control arm. These rejection denominators are not the full randomized population. The UK product information reports pneumonia in 5.6% and sepsis in 3.7% as the most common serious adverse reactions in the clinical studies supporting that document.