Ziltivekimab for treatment of anemia of inflammation in patients on hemodialysis: Results from a phase 1/2 multicenter, randomized, double-blind, placebo-controlled trial
Journal of the American Society of Nephrology Dec 08, 2020
Pergola PE, Devalaraja M, Fishbane S, et al. - Given that hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) is attributable to anemia of inflammation in CKD patients on hemodialysis, and a key mediator of such inflammation is interleukin-6 (IL-6) induced hepcidin expression, therefore, researchers evaluated impacts of ziltivekimab, a novel anti–IL-6 ligand antibody, in patients receiving hemodialysis with rs855791 (a single nucleotide polymorphism of the TMPRSS6 gene that is hypothesized to heighten susceptibility to IL-6–mediated inflammatory impacts) in this phase 1/2, placebo-controlled trial. A total of 61 patients with increased IL-6 (≥ 4 pg/ml) were randomly assigned to receive placebo or ziltivekimab (doses of 2, 6, or 20 mg), given intravenously every 2 weeks for 12 weeks during hemodialysis. Following 4 weeks, ESA dose adjustments were permitted. Findings revealed that treatment with ziltivekimab not only resulted in a significant improvement in markers of inflammation but also decreased ESA needs and raised serum albumin in patients on hemodialysis with inflammation and hyporesponsiveness to ESA therapy.
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