Dialysis patients may soon say goodbye to strict low-potassium diets
NCT ID NCT06858280
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether the drug patiromer can safely allow people on chronic dialysis to relax their strict low-potassium diet. About 40 participants will receive either patiromer or a placebo daily. The goal is to see if patiromer keeps potassium levels stable while patients eat more potassium-rich foods, potentially improving their nutrition and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- patiromer (Veltassa)
- What this could lead to
- If it works, this could allow dialysis patients to eat a more varied diet without risking dangerous potassium spikes, improving their quality of life.
- What could go wrong
- This is a small pilot trial with only 40 participants, so results may not apply to everyone. Patiromer can cause stomach upset or interact with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nephrology Unit, ASST Papa Giovanni XXIII
RECRUITINGBergamo, BG, 24127, Italy
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