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Potassium binder may unlock lifesaving heart drugs for seniors

NCT ID NCT06578078

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a potassium-lowering drug called sodium zirconium cyclosilicate (Lokelma) can help elderly patients with heart failure and chronic kidney disease safely take higher doses of RAASi medications, which are often limited by high potassium levels. The trial will enroll 94 people aged 70 and older, comparing those who get Lokelma plus standard RAASi therapy to those who get standard care alone. The main goal is to see if more patients can increase their RAASi dose by at least 25% over three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sodium Zirconium Cyclosilicate (Lokelma)
What this could lead to
If successful, this could show a way to safely use life-saving heart and kidney medications in elderly patients who currently cannot due to high potassium levels.
What could go wrong
This is a small, early-phase trial (94 participants) focused on medication dosing, not hard outcomes like survival. The drug may not meaningfully improve long-term health.

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 94 people

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

Started

Oct 2024

Expected to finish

Dec 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

70 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: * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Provision of informed consent form prior to any study specific procedures, sampling and analysis. * Individuals must be ≥ 70 years of age at the time of signing the informed consent form. * Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF). * Individuals must have previously been admitted to hospital due to HF decompensation requiring intravenous diuretics. * Individuals must have been stabilised for at least 24-48h of their HF decompensation before randomisation. * Individuals must have a confirmed diagnosis of Chronic Kidney Disease defined as a renal impairment of eGFR less than 60ml/min/1.73 m2. * Individuals receiving background standard of care for HF and treated according to international guidelines. Specific treatment should include RAASi and/or MRA treatment and at least should have been stable for ≥ 4 weeks at maximum tolerated doses. * Patients on RAASi blocker treatment with less than or equal to 75% of the maximum recommended dose. * Hyperkalemic patients (sK+ 5.1-5.9 mmol/L at screening / study enrolment) or Normokalemic patients at risk of developing HK defining as having a history of hyperkalaemia (sK+ \>5.0 mEq/L) within the prior 24 months and sK+ ≥4.5 mEq/L ≤ 5.1 mEq/L at inclusion Exclusion Criteria: * Limited life expectancy (less than 1 year) according to clinician's criteria, such as but not limited to malignancy, with life expectancy of less than 2 years based on investigator's clinical judgement. * sK \>6 mEq/litre or \<4.5mEq/litre or history of hypokalemic episodes (S-K\<3.5 mEq/L) during the last year. * Patients on haemodialysis or haemofiltration * NYHA functional class IV * Patients undergoing treatment with potassium binders. * Active tumour undergoing chemotherapy or metastasis or malignancy requiring treatment. * Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted. * QTc(f) \> 550 msec. * History of QT prolongation associated with other medications that required discontinuation of that medication. * Congenital long QT syndrome. * Prior history of hypersensitivity to a RAAS blocker drug, including but not limited to development of angioedema, icterus, hepatitis, or neutropenia or thrombocytopenia requiring treatment modification. Addison's disease or other causes of hypoaldosteronism. * Patients with a known hypersensitivity to SZC or any of the excipients of the product. * Individuals treated with potassium binding resins such as sodium polystyrene sulfonate (SPS, e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®) within 7 days prior to the first dose of study drug. * Treated with potassium supplements within 7 days prior to randomization. 15. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening. * Known to have tested positive for human immunodeficiency virus. * Known history of drug or alcohol abuse within 3 year of screening. * Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). * Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements. * Previous enrolment in the present study. * Participation in another clinical study with an investigational product during the last 3 months.

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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.

  1. The places running it

    6 sites. 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

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario Fundación Alcorcón

    NOT_YET_RECRUITING

    Alcorcón, Madrid, 28922, Spain

  • Hospital Universitario Nuestra Señora del Perpétuo Socorro

    RECRUITING

    Albacete, 02006, Spain

  • Hospital Universitario Reina Sofía

    NOT_YET_RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Severo Ochoa

    NOT_YET_RECRUITING

    Leganés, Madrid, 28914, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, 09006, Spain

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