OBJECTIVES: The Dialysis Outcomes and Practice Patterns Study (DOPPS) demonstrated that a high proportion of Italian patients on maintenance haemodialysis have elevated peak serum potassium (sK⁺), which is associated with increased risk of adverse outcomes. In the DIALIZE (NCT03303521) trial, sodium zirconium cyclosilicate (SZC) significantly increased the proportion of patients with end stage kidney disease who maintained predialysis sK⁺ 4.0–5.0 mmol/L versus placebo. This study assessed the projected impact of SZC versus placebo on clinical outcomes including kidney transplants in individuals on haemodialysis in Italy.

METHODS: A semi-Markov state transition model was used, comprising seven health states: haemodialysis with and without cardiovascular disease (CVD), kidney transplant with and without CVD, CV hospitalisation, CV and non-CV death. Non-CV hospitalisation was modelled as a transient event.

Population characteristics inputs and sK⁺-dependent risks of hospitalisation and death were informed by DOPPS-Italy data, while transplant rates were informed by an Italian registry study. Treatment efficacy was derived by sampling sK⁺ trajectories from DIALIZE SZC and placebo arms to predict peak sK⁺ across a four-month period. Outcomes were predicted over a lifetime horizon.

RESULTS: SZC treatment was estimated to reduce overall hospitalisations by 30.2 per 1,000 patients over the modelled time horizon compared with placebo. CV deaths were also reduced compared with placebo, by 55.1 CV deaths per 1,000 patients. The incremental increase in life years of 0.289 associated with SZC treatment compared with placebo led to 6.9 more kidney transplants per 1,000 patients over the time horizon.

CONCLUSIONS: Modelling using trial data from DIALIZE combined with real-world evidence from DOPPS-Italy indicate that management of hyperkalaemia with SZC in patients on haemodialysis may be associated with fewer hospitalisations and CV deaths. Additionally, treatment with SZC may allow more haemodialysis patients to survive to benefit from kidney transplantation and the anticipated associated improvements in quality of life.