Ziltivekimab Improves Anemia Parameters in Patients With CKD

Ziltivekimab, a novel anti-IL-6 ligand antibody, improves inflammation-related anemia in patients with chronic kidney disease (CKD), new study findings suggest.

In the original phase 2 RESCUE trial (NCT03926117), ziltivekimab significantly reduced high-sensitivity C-reactive protein (hsCRP) levels compared with placebo in patients with stage 3 to 5 CKD and an initial hsCRP level of 2mg/L or higher.

In the new analysis of exploratory endpoints from the trial, hemoglobin levels significantly increased 0.57, 1.05, and 0.99g/dL from baseline to week 12 among patients treated with subcutaneous ziltivekimab 7.5, 15, and 30mg (administered every 4 weeks), respectively, compared with placebo, Pablo E. Pergola, MD, PhD, of Renal Associates PA in San Antonio, Texas, and colleagues reported in the Journal of the American Society of Nephrology. Ziltivekimab treatment also was significantly associated with increases in serum iron levels (16.34, 28.82, 32.89µg/dL), total iron-binding capacity (14.23, 17.72, and 24.36µg/dL), and transferrin saturation (3.77%, 7.05%, 7.69%) at the 3 doses, respectively, over 12 weeks. Most patients had baseline hemoglobin levels of 11g/dL or higher.

A related phase 1/2 study found that ziltivekimab improves hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) in patients receiving maintenance hemodialysis.

No major safety concerns were reported. The groups all had similarly low rates of sustained thrombocytopenia, sustained neutropenia, anemia, and iron deficiency anemia.

“Together with the results from the phase 1/2 trial, the results of this analysis suggest a new therapeutic approach for treating anemia in patients with CKD,” Dr Pergola’s team wrote. “Treating inflammation, a significant underlying mechanism of disease in many patients with anemia in CKD, has the potential to increase Hb without the need for ESA or iron therapies.”

Disclosure: This research was supported by Novo Nordisk A/S. Please see the original reference for a full list of disclosures.

This article originally appeared on Renal and Urology News