Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial
This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.
• 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