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Study of sodium zirconium cyclosilicate compared to standard care for managing high blood potassium levels in patients with chronic kidney disease

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 clinical trial focuses on patients with hyperkalemia (high potassium levels in the blood) who also have chronic kidney disease. The study will test a medication called Lokelma (sodium zirconium cyclosilicate), which comes as a powder that is mixed with water and taken by mouth. The purpose is to compare how well Lokelma works versus standard treatment methods in managing high blood potassium levels in these patients.

The medication being studied, Lokelma, is a type of drug known as a cation exchanger that helps remove excess potassium from the body. Patients will receive either Lokelma powder at doses up to 10 grams per day or continue with their usual care for managing high potassium levels. The treatment period will last for 60 days, during which doctors will monitor the patients' potassium levels regularly.

During the study, patients will be randomly assigned to one of two treatment groups. One group will receive Lokelma, while the other group will follow standard treatment procedures. The study will track how many patients in each group achieve normal potassium levels over a period of 90 days. Blood tests will be performed throughout the study to measure 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.

Step 1
Initial assessment
Your blood potassium level will be measured. To participate, your level must be between 5.5-6.5 mEq/L at the selection visit
A second measurement will be taken at the randomization visit, where your level should be between 5.0-6.5 mEq/L
Your kidney function will be evaluated through blood tests to confirm chronic kidney disease
Step 2
Treatment assignment
You will be randomly assigned to receive either Lokelma (sodium zirconium cyclosilicate) or standard care
If assigned to Lokelma, you will receive the medication as an oral suspension
The medication will be available in two strengths: 5 grams or 10 grams powder for oral suspension
Step 3
Treatment period
The study will continue for 90 days
Your blood potassium levels will be checked at days 7, 30, 60, and 90
The main goal is to achieve a blood potassium level below 5.5 mEq/L
Step 4
Follow-up visits
Regular check-ups will be scheduled to monitor your progress
Blood tests will be performed to measure your potassium levels
Your kidney function will be monitored throughout the study
Step 5
Study completion
The study will conclude after the 90-day treatment period
A final assessment of your blood potassium levels will be performed
The overall study is expected to continue until January 2026

Who can join the trial?

8 criteria

Must have high blood potassium levels (between 5.5-6.5 mEq/L) at the first screening visit
Must have high blood potassium levels (between 5.0-6.5 mEq/L) at the randomization visit
Must be at least 18 years old
Must provide written informed consent before participating in any study procedures
Must have chronic kidney disease (not requiring dialysis) with either: - Reduced kidney function (filtration rate between 15-60 ml/min/1.73m²) or - Mildly reduced kidney function (filtration rate 60-90 ml/min/1.73m²) with protein in urine
Must be receiving standard heart failure treatment, including specific medications (RAASi and/or MRA) at stable doses for at least 4 weeks
For women who can become pregnant: - Must have a negative pregnancy test - Must use effective birth control methods (barrier method with spermicide) during the study and for 3 months after - Other acceptable birth control methods include implants, injections, IUD, or tubal ligation - Oral contraceptives alone are not sufficient
Women who are post-menopausal (1 year after last period) or surgically unable to become pregnant may also participate

Who cannot join the trial?

12 criteria

Age below 18 years old or above 75 years old
Currently receiving dialysis treatment (a procedure to remove waste products from the blood when kidneys don't work properly)
Severe hyperkalemia (very high potassium levels in blood) requiring emergency treatment
Currently pregnant or breastfeeding women
History of severe allergic reactions to Sodium zirconium cyclosilicate or similar medications
Participation in another clinical trial within the past 30 days
Presence of life-threatening conditions that could interfere with study participation
Inability to follow study procedures or attend scheduled visits
History of significant heart, liver, or other major organ failure
Use of medications that could interact with the study drug
Recent major surgery (within past 3 months)
Unstable medical conditions that require frequent medication changes

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Verified sites

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Hospital Universitario Dr Peset Aleixandre
Verified
Valencia, Spain
Hospital Vall d’Hebron
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Barcelona, Spain

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Investigated drugs

Sodium Zirconium Cyclosilicate (Lokelma)
is a medication used to treat high potassium levels (hyperkalemia) in the blood. It works by binding to excess potassium in the digestive system and removing it from the body. This medication is particularly important for patients with chronic kidney disease who often struggle with maintaining normal potassium levels.
RAASi
(Renin-Angiotensin-Aldosterone System inhibitors) are medications that help control blood pressure and protect kidney function. They are commonly used in patients with chronic kidney disease but may sometimes need to be discontinued if potassium levels become too high.
MRA
(Mineralocorticoid Receptor Antagonists) are medications that help manage heart failure and high blood pressure by blocking certain hormones in the body. Like RAASi, these medications may need to be discontinued if a patient develops high potassium levels.

Sodium Zirconium Cyclosilicate

What is already known about the treatment

Sodium Zirconium Cyclosilicate (Lokelma) - An oral potassium-binding medication administered in powder form that is mixed with water and taken by mouth to treat high potassium levels (hyperkalemia) in patients with chronic kidney disease. This medication works by binding to excess potassium in the digestive tract, preventing its absorption into the bloodstream and allowing it to be removed from the body through normal bowel movements. Lokelma belongs to the class of medications known as potassium binders and has been proven effective in clinical trials for rapidly normalizing potassium levels, with current medical literature supporting its use as a standard treatment option for hyperkalemia management in kidney disease patients.

Investigated diseases

Hyperkalemia
A condition where there is too much potassium in the blood, specifically above normal levels (typically over 5.5 mEq/L). It commonly occurs in people who have chronic kidney disease, as their kidneys cannot effectively remove excess potassium from the body. The condition develops gradually as potassium builds up in the bloodstream. When kidneys are not functioning properly, they struggle to maintain the delicate balance of potassium needed for proper muscle and nerve function. Hyperkalemia can affect how the heart and other muscles work in the body.
Chronic Kidney Disease
A long-term condition where the kidneys gradually lose their ability to filter waste and excess fluid from the blood. The disease progresses through several stages, during which kidney function steadily declines. As the condition advances, various chemicals and waste products begin to build up in the blood. The kidneys become less effective at maintaining proper levels of minerals and nutrients in the body. This condition often develops slowly over months or years.