Kidney Week

Abstract: FR-PO1074

Efficacy and Safety of Short-Term Treatment with Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia: Open-Label, Phase 3 Trial

Session Information

• Late-Breaking Clinical Trial Posters
  November 03, 2017 | Location: Hall H, Morial Convention Center
  Abstract Time: 10:00 AM - 10:00 AM

Category: Fluid, Electrolytes, and Acid-Base

• 704 Fluid, Electrolyte, Acid-Base Disorders

Authors

• Packham, David K., U. of Melbourne, Melbourne, New South Wales, Australia

David K. Packham,

• Fishbane, Steven, Hofstra Northwell Health School of Med., Great Neck, New York, United States

Steven Fishbane,

• Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States

Pablo E. Pergola,

• Lerma, Edgar V., UIC/ Advocate Christ, Oak Lawn, Illinois, United States

Edgar V. Lerma,

• Butler, Javed, Stony Brook U., Stony Brook, New York, United States

Javed Butler,

• Von haehling, Stephan, U. of Göttingen Medical Centre, Göttingen, Germany

Stephan Von haehling,

• Adler, Scott H., AstraZeneca, Gaithersburg, Maryland, United States

Scott H. Adler,

• Singh, Bhupinder, ZS Pharma Inc., part of AstraZeneca, San Mateo, California, United States

Bhupinder Singh,

• Lavin, Philip T., Boston Biostatistics Research Foundation, Framingham, Massachusetts, United States

Philip T. Lavin,

• McCullough, Peter A., Baylor U. Medical Center, Dallas, Texas, United States

Peter A. McCullough,

• Kosiborod, Mikhail, Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, United States

Mikhail Kosiborod,

• Spinowitz, Bruce S., New York Presbyterian Queens, New York, New York, United States

Bruce S. Spinowitz,

Background

Correction of hyperkalemia (HK) is important for the clinical management of patients (pts). Sodium zirconium cyclosilicate (ZS-9) is a selective, inorganic, potassium (K)-binder. We report results of ≤72h of ZS-9 treatment from the largest study of treated HK pts to date.

Methods

This international, open-label, single-arm trial with no dietary K or RAASi restrictions enrolled 751 outpatients (≥18y) with HK (K≥5.1mmol/L). Pts received 10g ZS-9 TID for 24–72h until normokalemic (K3.5–5.0 mmol/L; blood K measured by point-of-care device [iSTAT]). Treatment decisions were based on iSTAT K, generally considered to be highly accurate; efficacy endpoints were based on serum K from central lab per usual practice. Endpoints were achievement of normokalemia, overall response rate (%), change in K from baseline (ΔK), and adverse events (AE).

Results

99.3% of pts completed. By 24h, ΔK was -0.8 mmol/L (iSTAT, -14.9%; from 5.5 to 4.7 mmol/L) and -0.7 mmol/L (serum, -12.7%; from 5.6 to 4.9 mmol/L). Overall, 99.5% (95% CI [99%, 100%]) of pts achieved normokalemia by iSTAT and 77.9% (95% CI [75%, 81%]) by serum K. 100% of pts experienced a reduction in K (regardless of measurement method) with 92% having K reductions ≥0.5 mmol/L; 0.4% of pts had iSTAT K>5.0mmol/L and 22% had serum K>5.0mmol/L (Figure). 4.1% of pts experienced an AE. Most common were nausea (0.5%) and urinary tract infection (UTI; 0.5%); 1 pt each had peripheral edema and serum K3.0-<3.5mmol/L. UTI was the 1 SAE (resulting in the only hospitalization), and 2 pts discontinued due to AEs (UTI, flatulence, and upper abdominal pain). No deaths occurred.

Conclusion

ZS-9 rapidly and reliably normalized K in nearly all HK pts, with a safety profile similar to prior studies.

Funding

• Commercial Support –