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Study on Sodium Zirconium Cyclosilicate for Patients with Chronic Kidney Disease Stages 3b and 4 to Allow More Fruits and Vegetables in Their Diet

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called sodium zirconium cyclosilicate on patients with chronic kidney disease (CKD) at stages 3b and 4. The medication is available in two forms: Lokelma 10 g and Lokelma 5 g, both as a powder for oral suspension. The purpose of the study is to see if a diet rich in potassium, which includes the use of sodium zirconium cyclosilicate as a potential rescue treatment, does not lead to an unacceptable increase in blood potassium levels.

Participants in the study will follow a potassium-rich diet, and the effects will be monitored over a period of six weeks. The study will compare the changes in blood potassium levels from the beginning to the end of the study. Additionally, the study will observe other health indicators such as blood pressure, kidney function, and quality of life. The study will also look at the effects on bowel movements and the occurrence of severe hyperkalemia, which is a condition where there is too much potassium in the blood.

The trial aims to ensure that the potassium-rich diet, along with the use of sodium zirconium cyclosilicate, is safe for patients with chronic kidney disease. The study will help understand if this approach can be a viable option for managing potassium levels in these patients without causing harm. The trial is expected to start recruiting participants in early 2024 and will continue until early 2025.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older) and having chronic kidney disease stage 3b to 4.
The use of a renin-angiotensin system inhibitor is also required.
Step 2
Initial assessment
An initial assessment is conducted to measure baseline serum potassium levels.
Other assessments include ambulatory blood pressure, 24-hour albuminuria, urinary potassium and sodium excretion, plasma bicarbonate, and quality of life using the SF36 questionnaire.
Step 3
Dietary intervention
Participants follow a potassium-rich diet for six weeks.
The main objective is to observe if this diet, along with the use of sodium zirconium cyclosilicate (SZC) as a potential rescue treatment, does not cause an unacceptable increase in plasma potassium levels.
Step 4
Medication administration
Sodium zirconium cyclosilicate is administered orally as a powder for suspension, available in 10 g and 5 g doses.
The medication is used as needed to manage high potassium levels (hyperkalemia).
Step 5
Monitoring and evaluation
Serum potassium levels are monitored throughout the study, with a specific check one week after starting the study during a period without SZC.
The primary endpoint is the difference in serum potassium levels from baseline to six weeks.
Step 6
Secondary assessments
Secondary assessments include changes in ambulatory blood pressure, 24-hour albuminuria, urinary potassium and sodium excretion, plasma bicarbonate, quality of life, and stool consistency using the Bristol Stool Chart.
The incidence of severe hyperkalemia is also monitored.
Step 7
Completion of study
The study concludes after six weeks of dietary intervention and monitoring.
A final assessment is conducted to evaluate the outcomes and any changes in the measured parameters.

Who can join the trial?

3 criteria

Must be an adult, which means 18 years or older.
Have chronic kidney disease at stage 3b to 4. This means the kidneys are not working as well as they should, with a specific measure called eGFR between 44 and 15.
Currently using a type of medication called an inhibitor of the renin-angiotensin system, which helps manage blood pressure and kidney function.

Who cannot join the trial?

1 criterion

Patients with chronic kidney disease stage 3b to 4. This means the kidneys are not working well, and it's a more advanced stage of kidney disease.

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

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Investigated drugs

Sodium zirconium cyclosilicate is a medication used in this study to help manage potassium levels in patients with chronic kidney disease (CKD) stage 3b and 4. It works by binding to potassium in the digestive tract, which helps to lower the amount of potassium in the blood. This medication is used as a potential rescue treatment if a patient's potassium levels become too high while they are on a potassium-rich diet.

Sodium Zirconium Cyclosilicate

What is already known about the treatment

Sodium Zirconium Cyclosilicate – This medication is administered orally, typically in the form of a powder that is mixed with water. It is currently being studied in clinical trials for its use in patients with chronic kidney disease stages 3b to 4. The main therapeutic indication is to manage high potassium levels in the blood, a condition known as hyperkalemia. At the molecular level, it works by exchanging sodium ions for potassium ions in the gastrointestinal tract, thereby reducing potassium levels in the bloodstream. It is classified as a potassium binder in pharmacology.

Investigated diseases

Chronic Kidney Disease Stage 3b to 4 – Chronic kidney disease (CKD) is a condition characterized by a gradual loss of kidney function over time. In stage 3b, the kidneys are moderately to severely damaged, with a glomerular filtration rate (GFR) between 30 and 44 mL/min. By stage 4, the damage is severe, and the GFR drops to between 15 and 29 mL/min. As the disease progresses, waste products and excess fluids can build up in the body, leading to symptoms such as fatigue, swelling, and changes in urination. Patients may also experience complications like high blood pressure, anemia, and bone disease. Managing CKD involves monitoring kidney function and addressing symptoms to slow the progression of the disease.