Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Sodium zirconium cyclosilicate to allow liberal fruit and vegetable intake for patients with CKD stage 3b and 4 (LIBERAL study)

This study, called LIBERAL, is for people in the UK with a type of kidney disease (stages 3b to 4) where their kidneys don't work as well as they should. The main goal is to see if a medication called Lokelma (sodium zirconium cyclosilicate) can safely help patients eat more fruits and vegetables. These foods are usually limited for people with kidney disease because they can cause potassium levels in the blood to go too high, which can be dangerous. Researchers will give participants different doses of Lokelma or a dummy drug (placebo), and everyone will follow a diet rich in potassium for six weeks. They will then compare potassium levels to see if Lokelma is effective and safe, helping people enjoy a healthier diet.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Academisch Ziekenhuis Leiden

Enrolment target

Start

27 Feb 2024

Patients with chronic kidney disease stage 3b to 4

What is this study about?

When your kidneys don't work properly, as happens in chronic kidney disease (CKD), they can struggle to remove enough potassium from your body. Potassium is a mineral found in many foods, especially healthy ones like fruits and vegetables. If potassium levels in your blood become too high, it's called hyperkalemia, and it can be a serious health risk.

Because of this, people with CKD, particularly those in stages 3b and 4, are often told to limit their intake of potassium-rich foods. This can make it hard to eat a healthy, balanced diet with plenty of fruits and vegetables, which are important for overall health.

This study, named LIBERAL, is testing a new approach. It's looking to see if a medication called Lokelma can help people with CKD stages 3b and 4 include more fruits and vegetables in their diet without causing their potassium levels to become too high. Lokelma works by helping your body remove extra potassium. By joining this study, you could help researchers find a way for people with kidney disease to enjoy a wider variety of healthy foods.

Key takeaways

The study aims to help people with kidney disease eat more fruit and vegetables.
It tests a medicine called Lokelma to control potassium levels.
Participants will follow a potassium-rich diet for six weeks.
Your health will be closely monitored with blood tests and other assessments.
You have the right to withdraw from the study at any time.

Who may be eligible?

This study is looking for both men and women to take part. To be considered, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate too.

The most important health requirement is that you must have chronic kidney disease (CKD) at either stage 3b or stage 4. This means your kidneys aren't working as well as they could be and you might already be monitoring your diet carefully.

It's worth noting that the exact medical details of your kidney disease and other health conditions will be checked by the study doctors to make sure this trial is right and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with chronic kidney disease (CKD) stage 3b or 4?
Are you able to take a powdered medication by mouth?
Are you willing and able to follow a specific diet during the study?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either 5 or 10 grams of Lokelma powder, or a dummy treatment (placebo), to take by mouth every day. You'll also follow a special diet that includes more potassium-rich fruits and vegetables than you might normally eat. This part of the study lasts for six weeks.

During these six weeks, you'll have regular visits to the clinic. At these visits, doctors will take blood samples to check your potassium levels and other important health markers. They will also measure your blood pressure over 24 hours, collect urine samples, and ask you to fill out questionnaires about your quality of life. You'll also be asked to keep track of your bowel movements using a simple chart.

Before the main treatment starts, there's a short period without any study medication, to get a clear starting point for your potassium levels. The total duration of your active participation, including check-ups before, during, and after, will be clearly explained by the study team.

Potential risks and benefits

Participating in this study might offer you some personal benefits, such as receiving a potential new treatment that could help you eat a wider variety of healthy foods. Your health will also be closely monitored by medical professionals throughout the study. However, as with any medication, there can be risks or side effects from Lokelma, such as stomach upset or changes in other blood measurements, which the study doctors will explain in detail. There's also a chance your potassium levels could go too low or too high despite the medication. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands

Common questions

What is chronic kidney disease (CKD)?

CKD means your kidneys are damaged and can't filter blood as well as they should. Stages 3b and 4 mean the damage is moderate to severe.

What is Lokelma?

Lokelma is a medicine that helps remove excess potassium from your body, often used by people with kidney problems.

Why can't people with CKD eat many fruits and vegetables?

Many fruits and vegetables are high in potassium. For people with CKD, eating too much potassium can cause dangerous levels to build up in their blood.

Will I have to eat a special diet?

Yes, if you join the study, you will follow a diet that includes more potassium-rich fruits and vegetables than you might usually eat.

Will I definitely get the active medication?

In this type of study, participants are randomly assigned to receive either Lokelma or a dummy treatment (placebo). It's generally not known which you are receiving until after the study finishes, to ensure fair results.