Ongoing Clinical Trials for Hyperkalaemia
There are currently 5 clinical trials investigating different treatments for hyperkalaemia (also known as: hyperkalemia, high blood potassium). These studies are testing medications that help manage high potassium levels in the blood, particularly in patients with chronic kidney disease. The trials are taking place across several European countries including Spain, France, Romania, Poland, Germany, Italy, and the Netherlands.
Clinical trial locations
- France
- Germany
- Italy
- Netherlands
- Poland
- Romania
- Spain
Study of sodium zirconium cyclosilicate compared to standard care for managing high blood potassium levels in patients with chronic kidney disease
This trial, conducted in Spain, is testing a medication called Lokelma (sodium zirconium cyclosilicate) for patients with high potassium levels who also have chronic kidney disease. The study compares how well Lokelma works compared to standard treatment approaches.
Who can participate: Adults aged 18 years or older with high blood potassium levels (between 5.5-6.5 mEq/L at screening and 5.0-6.5 mEq/L at the start of treatment) who have chronic kidney disease but do not require dialysis. Participants must also be taking heart failure medications (RAASi and/or MRA) at stable doses for at least 4 weeks. Women who can become pregnant must use effective birth control methods.
Who cannot participate: People under 18 or over 75 years old, those currently on dialysis, individuals with very severe high potassium levels requiring emergency treatment, pregnant or breastfeeding women, and those with a history of severe allergic reactions to the study medication. People who have had recent major surgery (within 3 months) or have unstable medical conditions are also excluded.
What the study involves: The trial aims to achieve and maintain normal potassium levels over 90 days. Participants will be randomly assigned to receive either Lokelma powder (mixed with water and taken by mouth) at doses up to 10 grams per day or continue with standard care. Blood tests will be performed regularly at days 7, 30, 60, and 90 to monitor potassium levels.
Investigational drug: Lokelma works as a cation exchanger that helps remove excess potassium from the body through the digestive system. This medication is particularly designed for patients with chronic kidney disease who struggle to maintain normal potassium levels.
Study on Insulin Aspart, Salbutamol, and Glucose for Treating Acute Hyperkalemia in Emergency Department Patients
This French study is comparing three different emergency treatments for sudden high potassium levels: an intravenous infusion of insulin and dextrose (sugar), an inhaled medication called salbutamol, or a combination of both treatments.
Who can participate: Adults over 18 years old who arrive at the emergency department with high potassium levels (5.5 mmol/l or higher) confirmed by laboratory testing. Participants must be able to provide written informed consent before joining the study.
Who cannot participate: The study excludes vulnerable populations who may need special protection or care, pregnant or breastfeeding women, people currently in another clinical trial, those with severe health conditions that could interfere with the study, and anyone with a history of allergic reactions to the study medications.
What the study involves: The main goal is to determine which treatment most effectively reduces potassium levels within 60 minutes. Participants will be randomly assigned to one of three treatment groups, and their potassium levels will be monitored at 60 minutes, 180 minutes, and 24 hours after treatment begins. The study will also watch for heart rhythm problems and other side effects.
Investigational drugs: The trial tests insulin/dextrose infusion (which helps move potassium from blood into cells), nebulized salbutamol (an inhaled medication that also helps move potassium into cells), or a combination of both treatments.
Study on the Safety and Effectiveness of Sodium Zirconium Cyclosilicate for Children with High Potassium Levels
This international trial, taking place in Romania, Poland, Germany, and Spain, is studying the safety and effectiveness of Sodium Zirconium Cyclosilicate (SZC) in children with high potassium levels. This is the first major study of this medication in pediatric patients.
Who can participate: Children from birth to under 18 years old who require treatment for high potassium levels. Children aged 2 years and older must need long-term treatment, while those younger than 2 years can need either short-term or long-term treatment. Participants must meet specific criteria for high potassium levels and have normal heart rhythm measurements. Girls who can become pregnant must have a negative pregnancy test and use two forms of birth control.
Who cannot participate: Children with certain medical conditions that make participation unsafe, those unable to have repeated blood tests or lacking reliable vein access for blood sampling are excluded from the study.
What the study involves: The trial is divided into phases. First, a correction phase aims to achieve normal potassium levels within 3 days. Then a 28-day maintenance phase focuses on keeping potassium levels normal. An optional long-term maintenance phase may continue for participants who benefit from ongoing treatment. Regular blood tests will monitor potassium levels throughout the study.
Investigational drug: SZC (also known as Lokelma) is provided as a 5g powder that is mixed with water and taken by mouth. The medication works by binding to potassium in the digestive tract and removing it from the body.
Study on Patiromer and Placebo for Managing Hyperkalemia in Non-Dialysis Patients with Chronic Kidney Disease Stages IIIB to V
This Italian study is testing whether a medication called patiromer can help patients with advanced chronic kidney disease maintain their important kidney-protective medications (RAAS inhibitors) without developing dangerously high potassium levels.
Who can participate: Adults over 18 years old with chronic kidney disease stages 3b to 5 (kidney function measure GFR less than 45 ml/min/1.73m²) who are not on dialysis. Participants must have potassium levels above 5.0 mEq/L in at least two tests taken one week apart, despite following dietary advice and using other treatments. They must also be taking RAAS inhibitor medications and have normal magnesium levels.
Who cannot participate: People currently on dialysis, pregnant or breastfeeding women, those with severe liver disease, individuals who have had a heart attack or stroke within the last 6 months, people with uncontrolled high blood pressure, those participating in another clinical trial, and individuals with a history of severe allergic reactions to the study medication.
What the study involves: This is a double-blind study, meaning neither participants nor researchers will know who receives the actual medication or placebo. Participants will take Veltassa (patiromer) 8.4g powder mixed with water or a placebo. Regular follow-up visits will monitor potassium levels and other health markers to determine if patiromer allows patients to safely continue their RAAS inhibitor therapy.
Investigational drug: Patiromer is a potassium binder that works by attaching to potassium in the digestive tract, preventing its absorption into the bloodstream and allowing it to leave the body naturally.
Study on Sodium Zirconium Cyclosilicate for Patients with Chronic Kidney Disease Stages 3b and 4 to Allow More Fruits and Vegetables in Their Diet
This innovative Dutch study is exploring whether patients with chronic kidney disease can safely eat a diet rich in fruits and vegetables (which contain potassium) when using sodium zirconium cyclosilicate as a safety measure.
Who can participate: Adults aged 18 years or older with chronic kidney disease stage 3b to 4 (kidney function measure eGFR between 15 and 44) who are currently taking a renin-angiotensin system inhibitor medication to manage blood pressure and kidney function.
Who cannot participate: The study specifically focuses on patients with chronic kidney disease stages 3b to 4, so those outside this range would not be eligible.
What the study involves: Participants will follow a potassium-rich diet for six weeks while being monitored closely. The study will measure whether this dietary approach, with sodium zirconium cyclosilicate available as a rescue treatment if needed, causes an unacceptable increase in blood potassium levels. Regular assessments will track potassium levels, blood pressure, kidney function, and quality of life throughout the six-week period.
Investigational drug: Sodium zirconium cyclosilicate (available in 10g and 5g doses) works by binding to potassium in the digestive tract, reducing the amount absorbed into the blood. It is used as needed if potassium levels become too high during the study.
Summary
The five ongoing clinical trials for hyperkalaemia reflect different approaches to managing this condition. A notable trend is the focus on sodium zirconium cyclosilicate (also known as Lokelma or SZC), which appears in three of the five studies, including one specifically for children. This suggests growing interest in this potassium-binding medication.
The trials span multiple European countries, with Spain hosting two studies and other trials distributed across France, Italy, the Netherlands, Romania, Poland, and Germany. The international pediatric study demonstrates particular geographical diversity, taking place in four countries.
The studies address different patient populations and situations: acute emergency treatment (France), chronic management in adults with kidney disease (Spain, Italy, Netherlands), and safety evaluation in children (multi-country). Notably, the Dutch study takes a unique approach by examining whether patients can liberalize their diet while using medication as a safety measure, which could significantly improve quality of life.
Other medications being investigated include patiromer (Italy), insulin with dextrose, and salbutamol (France), showing that researchers are exploring multiple therapeutic options for managing high potassium levels in different clinical contexts.
