ASN's Mission

ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: PO0484

IL-6 Inhibitor Ziltivekimab Increases Serum Hemoglobin and Iron Biomarkers in Patients with CKD Stage 3–5: A RESCUE Trial Analysis

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Davidson, Michael, University of Chicago, Chicago, Illinois, United States
  • Devalaraja, Matt, Nipuna Therapeutics, Wilmington, Delaware, United States
  • Ivkovic, Milana, Novo Nordisk A/S, Søborg, Denmark
  • Johansen, Nicklas Järvelä, Novo Nordisk A/S, Søborg, Denmark
  • Raj, Dominic S., George Washington University School of Medicine, Washington, Washington, United States
  • Sode, Birgitte Fischer, Novo Nordisk A/S, Søborg, Denmark
  • Tuttle, Katherine R., University of Washington and Providence Health Care, Spokane, Washington, United States
  • Perkovic, Vlado, UNSW Sydney, Sydney, New South Wales, Australia
Background

Interleukin-6 (IL-6)-mediated inflammation causes functional iron deficiency and anemia in patients (pts) with chronic kidney disease (CKD). IL-6 inhibitor, ziltivekimab, reduced inflammation markers (RESCUE trial; NCT03926117) and improved anemia and serum albumin in hemodialysis pts (NCT02868229). We examined the effect of ziltivekimab on serum hemoglobin (Hb) and iron homeostasis in pts with CKD stage 3–5 in the RESCUE trial.

Methods

Changes in anemia markers from baseline (BL) to Week 12 were assessed in pts (CKD stage 3–5, high-sensitivity C-reactive protein ≥2 mg/L) treated with ziltivekimab 7.5, 15 or 30 mg vs placebo (PBO). The intention-to-treat population was analyzed using a mixed model for repeated measurements (no adjustment for multiplicity). Analysis by BL Hb level (<11 or ≥11 g/dL) was conducted.

Results

In the RESCUE trial overall, mean age was 66 years, median Hb 12.5 g/dL at BL (N=198, ziltivekimab; N=66, PBO). Ziltivekimab increased Hb from BL to Week 12 vs PBO (p<0.001 for each dose; Figure/Table), with numerically greater increases with ziltivekimab vs PBO in pts with BL Hb <11 g/dL than pts with BL Hb ≥11 g/dL (Table). Ziltivekimab increased serum iron levels (p<0.0001), total iron-binding capacity and transferrin saturation (both p<0.01) vs PBO. No major safety concerns were reported.

Conclusion

Ziltivekimab improved levels of Hb, serum iron and other iron biomarkers vs PBO in pts with CKD stage 3–5. By reducing inflammation and improving functional iron deficiency, ziltivekimab may improve anemia in pts with CKD.

Funding

  • Commercial Support