Evaluating Patiromer to Reduce Potassium Dietary Restrictions and Improve Quality of Life in Patients on Chronic Dialysis A Phase III Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

This trial studies patients with end-stage kidney disease who are on chronic dialysis therapy and face the challenge of managing high potassium levels hyperkalemia. It aims to evaluate whether the oral potassium binder patiromer can help reduce or remove the need for strict potassium dietary restrictions without increasing the risk of hyperkalemia. This phase III, randomized, double-blind, placebo-controlled study will explore how patiromer affects diet flexibility and health-related quality of life in these patients. Participants will be randomly assigned to receive either patiromer or a placebo daily for three months. The medication is taken every morning and is designed to lower potassium levels by binding potassium in the gut, exchanging it for calcium. The study controls for the number of dialysis sessions per week two versus three and carefully monitors how the treatment allows adjustments in potassium diet restrictions. Both groups will follow the same schedule, with medication separated by at least three hours from other oral drugs. Throughout the 12-week study, participants will have their serum potassium levels checked before each dialysis session. Researchers will monitor the safety and effectiveness of patiromer in maintaining potassium levels within a normal range while potentially improving diet and quality of life. The study includes careful tracking of side effects and overall health, aiming to find better treatment options for dialysis patients. Total participation lasts for three months of treatment with regular clinical assessments.

Patiromer and Diet/hrQoL in Chronic Dialysis