At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓Hospitalized inpatient (from ED or directly admitted)
- ✓Diagnosed CKD (any stage) OR eGFR <90 mL/min/1.73m² within 3 months of screening
- ✓Recent K+ measurement (within 24 hours of baseline) showing hyperkalaemia ≤6.5 mmol/L OR normokalaemia (3.5–5.0 mmol/L) with ongoing treatment for prior hyperkalaemia episode
- ✕Hospitalization for acute cardiovascular event within 12 weeks prior to screening
- ✕Unable to take oral SZC drug mix
- ✕Life expectancy less than 6 months
- ✕QT interval corrected by Fridericia method (QTcF) >550 msec
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge in Participants With Chronic Kidney Disease Treated for Hyperkalaemia
In Brief
A Phase 4 clinical trial evaluating Sodium Zirconium Cyclosilicate (SZC) and Local standard of care for Hyperkalaemia and Chronic Kidney Disease. Completed, enrolled 186 participants across 28 sites in 6 countries.
Detailed Summary
This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining: * If continued use of SZC maintains normokalaemia (NK) better than SoC after participant discharge from the hospital. * If continued use of SZC after discharge will reduce HK related healthcare resource utilisation compared to SoC.
Study Details
Timeline
Interventions
White to grey crystalline powder for oral suspension in 5 g sachets. Each sachet will be labeled in accordance with Good Manufacturing Practice Annex 13 and per country regulatory requirement. Label text will be translated into local language.
Local SoC in the country to be used as per local label