Clinical Research Directory

Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria): * More than 18-year-old * Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD * Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq/L confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia * Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics * On standardized and stable (moderately or strictly restricted) low-potassium diet * Compliance with recommended diet * Written informed consent Exclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial): * Hyperkalemia (pre-dialysis potassium \>5.5 mEq/L during the long interdialytic period) * Hypomagnesemia (serum magnesium \<1.7 mg/dL) * Hypercalcemia (serum calcium \>10.5mg/dl) * Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.) * Ongoing treatment with potassium-sparing diuretics * Pre-dialysis potassium \<4.0 mEq/L during the long interdialytic period * One or two weekly dialysis session * Poor compliance to prescribed potassium-restricted diet * History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders * Previous history of cardiac arrhythmias potentially related to hypokalemia * Known hypersensitivity to the active ingredient or any of the excipients of the study drug * Inability to fully understand the potential risks and benefits related to study participation * Concomitance of clinical conditions that could jeopardize the completion of the treatment period and/or confound data interpretation including: * Cancer (except non-metastatic cutaneous cancers) * Active systemic autoimmune diseases * Concomitant treatment with steroids or any other immunosuppressive agent * Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months * Refractory severe hypertension (BP \>180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications) * Known to be positive for human immunodeficiency virus * Drug or alcohol abuse * Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment * Intention to donate ova or sperm over the same period * Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01About\_HMA/Working\_Groups/CTFG/2020\_09\_HMA\_CTFG\_Contraception\_guidance\_Version\_1.1\_updated.pdf) * Involvement in the study planning and/or conduct * Participation in another clinical study with an investigational product during the last month