Kidney Week

Abstract: FR-PO0377

Effect of Clazakizumab on Neutrophil-to-Lymphocyte Ratio in Patients Receiving Maintenance Hemodialysis: Secondary Analysis of the POSIBIL6ESKD Phase 2b Trial

Session Information

• Hypertension and CVD: Clinical - 2
  November 07, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Hypertension and CVD

• 1602 Hypertension and CVD: Clinical

Authors

• Catanese, Benjamin Peter, Duke Health, Durham, North Carolina, United States

Benjamin Peter Catanese, MD

• Heise, Mark A., CSL Behring LLC, King of Prussia, Pennsylvania, United States

Mark A. Heise, PhD

• Chang, Anna Marie, Amgen Inc, Thousand Oaks, California, United States

Anna Marie Chang, MD, MS

• Chandhok, Gursimran, CSL Behring LLC, King of Prussia, Pennsylvania, United States

Gursimran Chandhok, MSc, PhD

• Velkoska, Elena, CSL Behring LLC, King of Prussia, Pennsylvania, United States

Elena Velkoska, PhD

• Luo, Jiyu, CSL Behring LLC, King of Prussia, Pennsylvania, United States

Jiyu Luo, PhD

• Chertow, Glenn M., Stanford University, Stanford, California, United States

Glenn M. Chertow, MD, MPH, FASN

• Wolf, Myles, Weill Cornell Medicine, New York, New York, United States

Myles Wolf, MD, MS, MSc

• Szecsödy, Peter, CSL Behring LLC, King of Prussia, Pennsylvania, United States

Peter Szecsödy, MD

• Edmonston, Daniel, Duke Health, Durham, North Carolina, United States

Daniel Edmonston, MD, FASN

Background

Few therapies improve cardiovascular (CV) outcomes in end-stage kidney disease. The neutrophil-lymphocyte ratio (NLR) is an emerging inflammatory biomarker which predicts major adverse CV events (MACE) in patients with atherosclerotic CV disease (ASCVD). In the POSIBIL₆ESKD phase 2b trial, clazakizumab, a monoclonal antibody against the interleukin-6 ligand significantly reduced high-sensitivity C-reactive protein (hs-CRP) in patients with ASCVD and/or diabetes on maintenance hemodialysis (HD). We determined the effects of clazakizumab on NLR.

Methods

We randomized patients on HD with elevated hs-CRP to receive either placebo or one of three doses of clazakizumab (2.5 mg, 5 mg, or 10 mg) every 4 weeks, we evaluated (post-hoc) the effect of clazakizumab (pooled) versus placebo on change in NLR at 12 weeks using a linear mixed model incorporating repeated measures of log-transformed NLR.

Results

Among 127 participants (96 clazakizumab, 31 placebo), mean age was 62 years and 33% were women. At 12 weeks, NLR decreased 30% (95% CI –38%, –21%) from baseline in the pooled clazakizumab group compared with essentially no change in the placebo group, 5% (95% CI –15%, 28%). The between groups change in NLR was –33% (95% CI: –47% to –15%; P=0.001) lower at 12 weeks in the clazakizumab group compared to placebo.

Conclusion

In addition to reducing hs-CRP, clazakizumab significantly reduced NLR, a biomarker associated with ASCVD and incident MACE, after 12 weeks in high-risk patients on HD. The Phase 3 component of the trial will provide definitive evidence on the effects of clazakizumab on CV outcomes in this population.

Figure: Repeated measures of NLR for the placebo and pooled clazakizumab groups

Funding

• Commercial Support – CSL Behring

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025rk623tg8