Abstract: TH-PO348
Updated Design and Status of CONTINUITY: A Phase 4 Study of Continued Postdischarge Sodium Zirconium Cyclosilicate in CKD
Session Information
- Sodium, Potassium, and Volume Disorders: Clinical
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Fluid, Electrolytes, and Acid-Base Disorders
- 1102 Fluid, Electrolyte, and Acid-Base Disorders: Clinical
Authors
- Burton, James, University of Leicester and University Hospitals of Leicester, Leicester, United Kingdom
- Amin, Alpesh, University of California Irvine, Irvine, California, United States
- Izquierdo, Maria Jesus, Hospital Universitario de Burgos, Burgos, Castilla y León, Spain
- Linde, Cecilia, Karolinska Institutet, Stockholm, Stockholm, Sweden
- Robles, Nicolas Roberto, Universidad de Extremadura, Badajoz, Spain
- Sood, Manish M., Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Allum, Alaster, AstraZeneca, Cambridge, United Kingdom
- Eudicone, James M., AstraZeneca, Wilmington, Delaware, United States
- Mohan, Katie, AstraZeneca, Cambridge, United Kingdom
Background
Patients (pts) hospitalized with hyperkalemia (HK) have increased risk of recurrent HK and re-hospitalization. The ongoing CONTINUITY study (NCT05347693) compares efficacy of continued post-discharge sodium zirconium cyclosilicate (SZC) treatment vs standard of care (SoC) in hospitalized pts with chronic kidney disease (CKD) and HK. We present protocol changes made to clarify eligibility criteria, better align inclusion/exclusion criteria with local practice, and ensure a more clinically relevant main secondary endpoint (Figure).
Methods
CONTINUITY is a randomized, open-label study across 6 European countries. Pts with CKD admitted to hospital with HK will be treated in hospital with SZC. At discharge, pts with normokalemia (NK; serum potassium [sK+] 3.5–5.0 mmol/L) are randomized 1:1 to SZC:SoC, per local label/practice, for 180 days. The primary endpoint evaluates SZC efficacy as part of discharge medications, vs SoC, in maintaining NK. The main secondary endpoint evaluates the effect of SZC as part of discharge medications, vs SoC, in reducing incidence of the composite outcome of all-cause hospital admissions, or emergency department visits with HK as a contributing factor, or all-cause death, or use of rescue-therapy for HK.
Results
As of May 2024, 179 pts were enrolled and 129 randomized (SZC n=65; SoC n=64) from Belgium (n=2), France (n=6), Italy (n=9), the Netherlands (n=1), Spain (n=109), and the UK (n=2); mean age 72 years, 29% female. Further baseline demographics/characteristics will be presented at Kidney Week 2024.
Conclusion
The CONTINUITY study (estimated completion: Dec 2024) will provide important evidence supporting either SoC or more active sK+ management with a K+ binder post discharge for pts with CKD admitted with HK. Protocol changes allow inclusion of a wider pt population and the potential to improve the clinical relevance of the results.
Funding
- Commercial Support – AstraZeneca