drugset / Trial / NCT04997161

Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia

NCT04997161 ↗

Phase 4 Terminated 3 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

Prescribing Sodium zirconium cyclosilicate (SZC) with enhanced nutritional advice to participants with hyperkalaemia on haemodialysis will reduce serum K+ (S-K+ ) and enable the consumption of more fruit and vegetables and more satisfying diet. The study aims to show that participants using SZC achieve S-K+ reduction as well as participants on SoC (other than K+ binders), without the need for restricting K+ in the diet.

Timeline

Start
2021-08-17
Primary completion
2021-11-17
Completion
2021-11-17

Outcome

Outcome not reported

Stopped: “There is disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice. The number of unknowns and differences make the results unlikely to be translatable into clinical practice and will not benefit patients.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Zirconium Cyclosilicate Other / unclassified — —

Indications

No indication recorded.