Patiromer and Diet/hrQoL in Chronic Dialysis

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