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Study of Patiromer to Allow Less Dietary Potassium Restrictions in Patients on Chronic Dialysis with Controlled Blood Potassium Levels

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with End Stage Kidney Disease who are receiving chronic dialysis therapy. The research examines the effects of patiromer, a medication that binds to potassium in the body, compared to placebo. The purpose is to determine if this treatment allows patients to reduce or eliminate their dietary restrictions on potassium-rich foods without increasing the risk of having high potassium levels in their blood.

The medication being tested, Veltassa, comes as a powder that is mixed with liquid and taken by mouth. Patients will receive either Veltassa or placebo for three months while continuing their regular dialysis treatment. During this time, doctors will monitor the amount of potassium in patients' blood and assess whether they can safely include more potassium-containing foods in their diet.

The study will track several health factors, including changes in blood potassium levels, quality of life, and whether patients need additional treatments to manage their potassium levels. The research will also monitor if patients can better tolerate certain heart and blood pressure medications that are typically challenging to use in dialysis patients due to their effects on potassium levels.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your pre-dialysis blood potassium levels will be checked during two consecutive weeks to confirm they are between 4 to 5.5 mEq/L

    You must be on a stable low-potassium diet and receiving regular dialysis three times per week for at least three months

  2. Step 2

    Random assignment

    You will be randomly assigned to receive either Veltassa 8.4g powder (patiromer) or a placebo

    Neither you nor your healthcare provider will know which treatment you are receiving

  3. Step 3

    Treatment period

    You will take the assigned medication as an oral suspension daily

    Your diet restrictions may be adjusted based on your response to treatment

    Regular blood tests will monitor your potassium levels

    Your quality of life will be evaluated using specific questionnaires

  4. Step 4

    Monitoring

    Your blood potassium levels will be regularly checked before dialysis sessions

    Any symptoms such as muscle weakness, fatigue, numbness, or tingling in hands or feet will be monitored

    Your heart rhythm will be checked to ensure safety

    Your blood pressure will be monitored regularly

  5. Step 5

    Study completion

    The study will evaluate if your potassium diet restrictions can be safely reduced

    Final assessments will include blood tests and quality of life questionnaires

    The study duration will be from July 2025 to March 2026

Who can join the trial?

7 criteria

  • Age must be over 18 years old
  • Must be receiving regular dialysis treatment (3 sessions per week) for at least 3 months due to End Stage Kidney Disease
  • Must have blood potassium levels between 4 to 5.5 mEq/L before dialysis (measured during the long period between dialysis sessions) confirmed over two consecutive weeks, without any signs of high potassium levels
  • Must be on a stable treatment (for at least 3 months) with medications that affect blood pressure and fluid balance (RAS inhibitors or MRAs). Cannot be taking medications that retain potassium
  • Must follow a restricted low-potassium diet that is either moderately or strictly controlled
  • Must be able to follow dietary recommendations consistently
  • Must provide written informed consent to participate in the study

Who cannot join the trial?

13 criteria

  • Age below 18 years
  • Patients with severe hyperkalemia (blood potassium levels above 5.5 mEq/L)
  • Patients not currently receiving regular dialysis therapy (a treatment that filters waste from blood when kidneys don't work properly)
  • Patients who cannot maintain stable potassium levels through dietary restrictions
  • Patients who have participated in other clinical trials within the past 30 days
  • Pregnant or breastfeeding women
  • Patients with severe allergic reactions to medications
  • Patients unable to follow dietary instructions
  • Patients with severe heart conditions
  • Patients with life-threatening conditions requiring immediate medical intervention
  • Patients unable to provide informed consent
  • Patients with conditions that could interfere with study medication absorption
  • Patients taking medications that could interact with the study drug
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Investigated drugs

Patiromer is a medication that helps control potassium levels in the blood. It works by binding to excess potassium in your digestive system and removing it from your body. This medication is particularly useful for people on dialysis who need to manage their potassium levels. It may help patients have more flexibility in their diet by reducing the need for strict potassium restrictions in food choices.

What is already known about the treatment

Patiromer – A potassium-binding medication administered orally that works by capturing excess potassium in the digestive system and removing it from the body through normal bowel movements. This medication belongs to the class of potassium binders and is primarily used in patients with end-stage kidney disease who are on dialysis to help manage high potassium levels (hyperkalemia) in their blood. At the molecular level, patiromer exchanges calcium for potassium in the gastrointestinal tract, effectively reducing potassium absorption and helping maintain safe potassium levels, particularly important for dialysis patients who often struggle with dietary potassium restrictions.

Investigated diseases

End Stage Kidney Disease - A condition where the kidneys have permanently lost their ability to function effectively, filtering less than 15% of normal kidney capacity. The disease develops gradually as kidney function deteriorates over time, leading to the build-up of waste products and excess fluid in the body. Patients experience various complications including problems with maintaining proper levels of minerals in the blood, particularly potassium. The condition requires regular dialysis treatments to artificially filter the blood. Common symptoms include fatigue, swelling in legs and ankles, and changes in urination patterns. The disease affects the body's ability to produce hormones that help control blood pressure and make red blood cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521378-33-00Protocol codePRINCEEstimated enrolment40 patientsSponsorIstituto Di Ricerche Farmacologiche Mario Negri

sourced from the EU Clinical Trials Register and site verification

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