Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Dialysis patients may soon say goodbye to strict low-potassium diets

NCT ID NCT06858280

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic kidney disease stage 3 and 4 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Nephrology Unit, ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, BG, 24127, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.