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The following is a summary of “Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3–5: An Analysis of a Randomized Trial (RESCUE),” published in the January 2024 issue of Nephrology by Pergola et al.

Ziltivekimab, being a fully human monoclonal antibody targeting the IL-6 ligand, demonstrated a significant reduction in inflammation biomarkers compared to placebo in the Phase 2 RESCUE clinical trial, focusing on patients with chronic kidney disease (CKD) and systemic inflammation (high-sensitivity C-reactive protein ≥2 mg/L).

Researchers conducted a retrospective subanalysis of RESCUE trial data to evaluate the impact of ziltivekimab on hemoglobin levels and iron balance within this specific patient cohort.

They analyzed exploratory endpoints using data from the RESCUE trial, involving 264 adults diagnosed with CKD stage 3–5 and high-sensitivity C-reactive protein levels ≥2 mg/L. Participants were randomly assigned to receive either placebo or subcutaneous ziltivekimab (7.5, 15, or 30 mg) in a 1:1:1:1 ratio once every four weeks for up to 24 weeks. The primary endpoints for this analysis focused on assessing changes in hemoglobin levels and biomarkers related to iron homeostasis from baseline to week 12.

The results showed that there was a significant increase in Hb levels from baseline to week 12 with ziltivekimab 7.5, 15, and 30 mg (differences versus placebo: +0.57 g/dl [95% CI, 0.27 to 0.86], +1.05 g/dl [0.76 to 1.33], and +0.99 g/dl [0.70 to 1.28], all P<0.001). Ziltivekimab increased serum iron levels, total iron-binding capacity, and transferrin saturation from baseline to week 12 (P<0.05 versus placebo for all doses and comparisons). Instances of sustained thrombocytopenia, neutropenia, anemia, and iron deficiency anemia were rare and comparable across all groups.

Investigators concluded that Ziltivekimab, an anti-inflammatory therapy, improved anemia and iron homeostasis markers in individuals with stage 3–5 CKD and systemic inflammation, suggesting its potential for anemia management.

Source: journals.lww.com/jasn/fulltext/2024/01000/effect_of_ziltivekimab_on_determinants_of.8.aspx