Kidney Week

Abstract: FR-PO0502

Effects of Lumasiran in Patients with Hyperoxalemia on Maintenance Haemodialysis

Session Information

• CKM: Clinical - Trials, Epidemiology, and Biomarkers
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Cardiovascular-Kidney-Metabolic Health

• 602 Cardiovascular-Kidney-Metabolic Health: Clinical

Authors

• Hawkins-van der Cingel, Gerlineke M C, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Gerlineke M C Hawkins-van der Cingel, MBBS

• Khadzhynov, Dmytro, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Dmytro Khadzhynov, MD

• Pashyna, Anastasiia, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Anastasiia Pashyna

• Staeck, Oliver, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Oliver Staeck, MD

• Najenson, Ana Clara, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Ana Clara Najenson, PhD

• Seltzsam, Steve, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Steve Seltzsam, DrMed

• Schrezenmeier, Eva Vanessa, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Eva Vanessa Schrezenmeier, MD

• Eckardt, Kai-Uwe, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Kai-Uwe Eckardt, MD

• Knauf, Felix, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Felix Knauf, MD

Background

Cardiovascular death remains the leading cause of death in people with ESKD, with limited improvement in cardiovascular mortality and morbidity compared to the general population. Previous cohort studies have shown that hemodialysis patients with elevated plasma oxalate concentrations have increased risk of cardiovascular events, especially sudden cardiac death.

Methods

We investigated the efficacy and safety of lumasiran (3mg/kg) in hemodialysis patients with a non-primary hyperoxaluria cause of ESKD and a plasma oxalate concentration of >20uM in a randomized, double-blind placebo-controlled phase II trial. The primary outcome was the percentage change in pre-dialysis plasma oxalate levels from baseline to month 3- 6.

Results

The study was conducted in 29 patients with ESKD receiving hemodialysis for a minimum of 2 months. A total of 26 patients completed the trial period. For the primary end point of plasma oxalate percentage change, there was no statistically significant treatment effect at any of the time points. At month 6 the pooled pairwise comparison of placebo versus lumasiran was estimated at -11.32% change in plasma oxalate without significant a treatment effect (p= 0.174, 95% CI [-27.64, 5.00]). No significant differences were observed in the secondary end points. Two deaths were reported during this trial which were not related to the trial procedures or trial drug. There were no safety concerns and lumasiran was very well tolerated.

Conclusion

In this randomized controlled phase II trial, lumasiran did not result in a statistically significant reduction in plasma oxalate concentrations in hemodialysis patients with non-primary hyperoxaluria; and no treatment effect was observed across primary or secondary endpoints. Notwithstanding this overall negative result, a subset of patients in the treatment arm demonstrated marked reductions in plasma oxalate. This suggests heterogeneity in therapeutic response, underscoring the need to better characterize patient-specific determinants of response to lumasiran treatment.

Funding

• Commercial Support – This was an investigator initiated study with financial support from Alnylam