RecruitingPhase 3NCT06858280

Patiromer and Diet/hrQoL in Chronic Dialysis

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

Sponsor

Mario Negri Institute for Pharmacological Research

Enrollment

40 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

Dietary Intervention Chronic Kidney Disease Stage 3 and 4 Hyperkalaemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patiromer (a medication that lowers potassium levels in the blood) can allow dialysis patients with kidney failure to follow a less restrictive diet and improve their quality of life, while still keeping potassium levels safe. **You may be eligible if...** - You are 18 or older - You have end-stage kidney disease and have been on stable dialysis 3 times per week for at least 3 months - Your potassium levels before dialysis are between 4 and 5.5 mEq/L (confirmed on two separate weeks) - You are on stable blood pressure or heart medications (RAS inhibitors or MRAs) for at least 3 months - You are already following a low-potassium diet **You may NOT be eligible if...** - You have symptoms of high potassium (hyperkalemia) - You are taking potassium-sparing diuretics - You are not compliant with the recommended diet - You do not meet other lab or health criteria specified by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPatiromer 8400 MG [Veltassa]

Randomized patients will receive one 8.4 g packet of patiromer per day or one identical packet containing a placebo. To minimize the possibility of interference with gastrointestinal absorption of other orally administered medications, administration of patiromer will be separated by at least 3 hours from other oral medicinal products. Throughout the whole study period, the study drug will be administered every day in the morning.

DRUGPlacebo

Randomized patients will receive one packet of placebo identical to that of patiromer. Following the same treatment sequence of patiromer, administration of the placebo will be separated by at least 3 hours from any other oral medicinal products. As for patiromer, the placebo will be administered every day in the morning.