Potassium binder may let kidney patients keep Life-Saving heart drugs
NCT ID NCT06578533
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether sodium zirconium cyclosilicate (Lokelma) controls high potassium better than the usual approach of reducing or stopping RAASi and MRA medicines in people with chronic kidney disease. The trial enrolls adults with potassium levels between 5.0 and 6.5 mEq/L who take these heart and kidney protective drugs. Participants receive either Lokelma three times daily or standard care, and researchers track whether potassium drops below 5.5 mEq/L over 90 days.
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, a drug that removes potassium from the body
- What this could lead to
- If it works, people with chronic kidney disease and high potassium could keep taking their heart and kidney protective medicines instead of lowering or stopping them.
- What could go wrong
- The trial is small and open-label, so results may not hold up in larger studies. Lokelma can lower potassium too far, and the trial stops the drug if levels drop below 3.0 mEq/L.
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 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Jul 2027
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: * Patients must present serum potassium levels of 5.5-6.5 mEq/L at patient selection visit (V0) * Patients must present serum potassium levels of 5.0-6.5 mEq/L at randomization visit (V1). * Provision of patient or legal representative informed consent prior to any study specific procedures. * Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and/or MRA treatment at first consultation and at least should have been stable for ≥ 4 weeks at maximum tolerated doses. * Patients with CKD not on dialysis (Stages 2-5: estimated glomerular filtration rate (eGFR) between 15-60 ml/min/1,73m2 or eGFR between 60-90 ml/min/ 1.73 m2 with albuminuria/creatinuria (\> 30 mg/g) in the previous three months). The estimated GFR can be reported by the laboratory or calculated by the researcher with serum creatinine, age, and sex (CKD-EPI equation). * 18 years at the time of signing ICF. * Negative pregnancy test (urine or serum) for female subjects of childbearing potential. * Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign ICF) and for 3 months after the last dose of SZC. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used. Exclusion Criteria: * Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). * Previous enrollment or randomization in the present study. * HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease. * Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment. * Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrollment or planned to undergo any of these operations after randomization). * Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device. * Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization * Oropharingeal dysfunction that precludes normal swallow. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Patients with amputated limbs or pacemaker devices will be excluded of bioimpedance analysis. * Participation in another clinical study with an investigational product during the last 6 months. * Patients with a known hypersensitivity to SZC or any of the excipients of the product. * 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. * 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. * Subjects with a family history of long QT syndrome, presence of cardiac arrhythmias or conduction defects that require immediate treatment, or a QTc (corrected QT interval) of ≥ 550 msec. * History of QT prolongation associated with other medications that required discontinuation of that medications. * Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
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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
5 sites. 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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Hospital Clínico Universitario de Valencia
RECRUITINGValencia, 46010, Spain
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Hospital General Universitario Dr. Balmis
RECRUITINGAlicante, 03010, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario Doctor Peset
RECRUITINGValencia, 46017, Spain
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Hospital Universitario Vall d'Hebrón
RECRUITINGBarcelona, 08035, Spain
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