Keeping RAASi Treatment With Optimal Potassium Control
NCT Number: NCT06578533
Acronym: KEEP-ON
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Sodium Zirconium Cyclosilicate
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-09-30
Completion Date: 2026-07-30
Locations: Hospital General Universitario Dr. Balmis, Alicante, 03010, Spain|Hospital Universitario Vall d'Hebrón, Barcelona, 08035, Spain|Hospital Universitario 12 de Octubre, Madrid, 28041, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital Universitario Doctor Peset, Valencia, 46017, Spain

Summary:
Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).

Primary Outcome Measures: Percentage of patients achieving serum potassium < 5.5mEq/L at three or all timepoints (7, 30, 60 or 90 days) after follow up (90 days) in both groups., To analyze the proportion of patients achieving sK of \< 5.5 mEq/L with Sodium zirconium cyclosilicate (SZC) versus discontinuation of RAASi and/or MRA in patients with hyperkalemia and non dialysis CKD., Through study completion, an average of 1 year
Secondary Outcome Measures: Percentage of patients achieving serum potassium < 5 mEq/L at two of the four temporal points in both groups., To determine if the percentage of patients achieving serum potassium \< 5 mEq/L at two of the four temporal points is not inferior in SZC compared to RAASi / MRA discontinuation or downtitration., Through study completion, an average of 1 year|Number of patients treated with SZC with reduction of serum potassium > 20% after baseline in each time point., To determine the number of patients treated with SZC who effectively reduce serum potassium \> 20 % over the baseline at days 7, 30, 60 and 90 compared to RAASi / MRA discontinuation or downtitration., Through study completion, an average of 1 year|Percentage of patients achieving serum potassium below 5, 5.5, 6, 6.5 mEq/L in each time point., To compare percentage of patients achieving serum potassium below 5, 5.5, 6, 6.5 mEq/L at days 7, 30, 60 and 90 in both groups., Through study completion, an average of 1 year|Percentage of patients requiring additional treatments for hyperkalemia in both groups (potassium binding resins, adding or increasing loop diuretics, or discontinuation of RAASi and/or MRA in Lokelma group., To compare the need for additional treatments for serum hyperkalemia between both groups during the study (potassium binding resins, adding or increasing loop diuretics if hypervolemia)., Through study completion, an average of 1 year|Mean change in the urine albumin-to-creatinine ratio (UACR) at 90 days from baseline in patients treated with SZC compared to RAASi / MRA discontinuation or downtitration., To compare albuminuria changes at 90 days from baseline., Through study completion, an average of 1 year
Other Outcome Measures: Mean and standard deviation comparation scores between groups at baseline and at the end of the study (visit 1 and 7) (MLHFQ and SF-36), To demonstrate an improvement in health-related quality of life in this patient population in patients treated with SZC when compared to the patients non treated with the drug., Through study completion, an average of 1 year|Proportion of patients in each group with downtitration (decrease 25 %, 50 % 75 % or discontinuation of RAASi or MRI) during the study., To determine the number of patients treated with SZC who effectively need RAASi / MRA discontinuation or downtitration., Through study completion, an average of 1 year|Difference between mean hydration percentage with respect to baseline (OH/ECV *100) measured by multifrequency bioimpedance (BCM, Fresenius) at 90 days., Changes in relative overhydration: (OH/ECV \*100)., Through study completion, an average of 1 year|Proportion of patients treated with SZC presenting adverse events, in comparison to the patients non-treated with SZC, at 7, 30, 60 and 90 days, To evaluate the safety and tolerability of SZC in relation to the patients non treated with the drug., Through study completion, an average of 1 year