P0200KEEP ON (KEEPING RAAS INHIBITION TREATMENT WITH OPTIMAL POTASSIUM CONTROL). DESIGN OF A CLINICAL TRIAL OF USING SODIUM ZIRCONIUM CYCLOSILICATE FOR KEEPING RAAS INHIBITION AND/OR MRAS IN PATIENTS WITH CKD AND CONGESTIVE HEART FAILURE HISTORY

Abstract Background and Aims Hyperkalemia (HK) is a potentially life-threatening condition, in patients with chronic kidney disease (CKD) and congestive heart failure (CHF). The majority of patients affected with CKD or CHF, must be treated with inhibitors of renin angiotensin aldosterone system (RAASi) and mineralocorticoid receptor antagonists (MRAs). However, the treatments previously mentioned, increase the risk of HK episodes, which is the main cause of RAASi and MRAs downtitration or discontinuation, representing an undesirable clinical scenario, given that the patients are at high risk of be deprived of their nephroprotective effect and cardio-renal benefits The aim of the study is: to analyze if, in patients with HK, CKD and CHF treated with RAASi and/or MRA, serum potassium (sK) reduction by Sodium zirconium cyclosilicate (SZC) treatment is non-inferior to RAASi and/or MRAs discontinuation or downtitration. Method Design: Randomized, Multicentric, open label, parallel-group, non-inferiority 12 weeks trial, comparing SZC vs discontinuation or downtitration of RAASi and /or MRA as standard of care. Key Inclusion Criteria: Patients with hyperkaliemia (defined as sK: 5.5-6.5 mEq/L) and non dyalisis CKD (Stages 2-5) and previous history of CHF (cardiorenal syndrome), receiving RAASi and / or MRAs. Primary efficacy end-point: To determine the proportion of patients achieving sK 20 % over the baseline at 7, 30, 60 and 90 days. To evaluate the implication of SZS treatment on the reduction of the necessity of additional treatment for hyperkaliemia compared to RAASi and/or MRAs discontinuation. To measure the impact of the treatment of SZC on the quality life of HK patients measured by KDQoL questionnaire (Self-Assessment Questionnaire). To measure the changes in albuminuria at 90 days from baseline. Sample size calculation: Proportion of patients reaching sK of