Update from ZS-9 HARMONIZE Trial - CRRTonline · Sodium Zirconium Cyclosilicate: Update from ZS-9...
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Sodium Zirconium Cyclosilicate: Update from ZS-9 HARMONIZE Trial Bruce Spinowitz, M.D. FACP Associate Director, Nephrology Vice Chairman, Medicine New York Hospital Queens Clinical Professor of Medicine Cornell University Medical Center
Transcript of Update from ZS-9 HARMONIZE Trial - CRRTonline · Sodium Zirconium Cyclosilicate: Update from ZS-9...
Sodium Zirconium
Cyclosilicate:
Update from ZS-9
HARMONIZE Trial
Bruce Spinowitz, M.D. FACP Associate Director, Nephrology
Vice Chairman, Medicine New York Hospital Queens
Clinical Professor of Medicine Cornell University Medical Center
Background
ZS-9 Mechanism of Action
ZS004 HARMONIZE
Current Treatment Options for Hyperkalemia are Limited
Kosiborod, M et al. JAMA 2014, presented at AHA 2014
Stravos et al. PlosONE 2014
Non-Specific Polymer Resin Action in GI Tract
Background
ZS-9 Mechanism of Action
ZS004 HARMONIZE
ZS-9 :Novel, First-in-Class, Inorganic Crystalline Compound Designed Specifically to Trap Potassium
Stravos et al. PLOS ONE 2014
ZS-9 Action in GI Tract
Stravos et al. PLOS ONE 2014
ZS-9 is More Selective for Potassium than SPS
Stravos et al. PLOS ONE 2014
Packham, D. et al. N Engl J Med 2014; Kosiborod, M. et al. JAMA 2014
Background
ZS-9 Mechanism of Action
ZS004 HARMONIZE
Clinical Trial Design
Efficacy
Safety
Conclusions
ZS004 Second Phase 3 Study Design
Kosiborod, M et al. JAMA 2014
Kosiborod, M et al. JAMA 2014
Study Endpoints
Kosiborod, M et al. JAMA 2014
Study Population
Kosiborod, M et al. JAMA 2014
Baseline Characteristics
Kosiborod, M et al. JAMA 2014
Background
ZS-9 Mechanism of Action
ZS004 HARMONIZE
Clinical Trial Design
Efficacy
Safety
Conclusions
ZS004 Highlights
Kosiborod, M et al. JAMA 2014
HARMONIZE Trial Results: Open-Label Phase
Kosiborod, M et al. JAMA 2014
HARMONIZE Trial Open Label Phase: Consistent Efficacy in All Subgroups
Kosiborod, M et al. JAMA 2014
HARMONIZE Trial Achieves Primary Endpoint, Mean K+ Maintenance on Days 8-29 for All Doses
Kosiborod, M et al. JAMA 2014
HARMONIZE Trial Randomized Phase: Mean Potassium Levels Over Time
Kosiborod, M et al. JAMA 2014
HARMONIZE Trial Randomized Phase: Proportion of Patients with Mean K <5.1 mEq/L during Days 8-29
Kosiborod, M et al. JAMA 2014
Randomized Phase: Efficacy Consistent in All Subgroups
Kosiborod, M et al. JAMA 2014
Background
ZS-9 Mechanism of Action
ZSOO4 HARMONIZE
Clinical Trial Design
Efficacy
Safety
Conclusions
HARMONIZE Trial Safety and Tolerability
Kosiborod, M. et al. JAMA 2014
Safety Information (2 of 2)
Kosiborod, M. et al. JAMA 2014
Consistent Profile of Other Safety Data of Interest Throughout ZS-9 Clinical Program
Kosiborod, M. et al. JAMA 2014
Background
ZS-9 Mechanism of Action
ZS004 HARMONIZE
Conclusion
Conclusions
Kosiborod, M. et al. ZS Pharma R&D Analyst Day, NYC, 2014
