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Kidney Week

Abstract: FR-PO550

Effects of Sodium Zirconium Cyclosilicate (SZC) on CKD Progression: Rationale and Design of the Phase 3 STABILIZE-CKD Trial

Session Information

Category: Fluid‚ Electrolyte‚ and Acid-Base Disorders

  • 1002 Fluid‚ Electrolyte‚ and Acid-Base Disorders: Clinical


  • Bakris, George L., University of Chicago, Chicago, Illinois, United States
  • Eckardt, Kai-Uwe, University of Erlangen-Nürnberg, Erlangen-Nuremberg, Germany
  • Greene, Tom, University of Utah Health Sciences, Salt Lake City, Utah, United States
  • Pollock, Carol A., University of Sydney, Sydney, New South Wales, Australia
  • Toto, Robert D., University of Texas Southwestern Medical Center, Dallas, Texas, United States
  • Weir, Matthew R., University of Maryland, Baltimore, Maryland, United States
  • Al-shurbaji, Ayman, AstraZeneca, Gothenburg, Sweden
  • Guzman, Nicolas Jose, AstraZeneca, Gaithersburg, Maryland, United States
  • Lisovskaja, Vera, AstraZeneca, Gothenburg, Sweden
  • Wessman, Peter, AstraZeneca, Gothenburg, Sweden
  • Zhao, Yanli, AstraZeneca, Gaithersburg, Maryland, United States
  • Chertow, Glenn, Stanford University, Stanford, California, United States

Patients with CKD who may benefit from angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) therapy frequently discontinue or do not receive ACEi/ARB therapy at recommended doses due to hyperkalemia (HK) or HK risk, and thus do not experience maximal renoprotection. We hypothesize that SZC, an oral anti-hyperkalemic, will enable ACEi/ARB optimization and slow CKD progression in patients with HK or high HK risk.


This Phase 3, international, randomized withdrawal, parallel-group trial is enrolling adult patients with CKD and HK on ACEi/ARB therapy, or CKD and normokalemia on limited/no ACEi/ARB therapy due to HK or high HK risk (NCT05056727; Figure). After establishing normokalemia with SZC (without ACEi/ARB dose change; initiation phase), lisinopril or valsartan therapy will be up-titrated to guideline-recommended doses while continuing SZC (run-in phase), then patients will be administered SZC or placebo (in a double-blind randomized fashion) and lisinopril or valsartan for up to 24 months (maintenance phase), with repeated estimated glomerular filtration rate (eGFR) measurements.


The primary endpoints are eGFR measures from randomization to end of study (EOS) and from 12 weeks after randomization to EOS. Secondary endpoints include time to a kidney composite endpoint and time to first lisinopril or valsartan dose decrease. Safety and tolerability will be assessed by an independent data monitoring committee.


The STABILIZE-CKD study will assess if SZC attenuates CKD progression in patients treated with ACEi or ARB with HK or high HK risk.

Study Design


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