The purpose of this study is to see how well patiromer can lower potassium levels in young children over a period of 28 days when different amounts of the medicine are given. The study will also check how safe the medicine is for children and whether it causes any unwanted effects. During the study, children will take patiromer every day, and doctors will measure their potassium levels at different times, including on days 3, 7, 14, and 28. The medicine can be given through regular feeding or through feeding tubes if needed. Blood tests will be done to check not only potassium levels but also other important substances in the blood like magnesium, calcium, and other minerals to make sure they stay within healthy ranges.

The study is divided into two parts, and there is also an optional period where children can continue taking the medicine for a longer time if their doctor thinks it would be helpful. Throughout the study, doctors will carefully watch for any side effects and will check the children’s heart function, vital signs like blood pressure and heart rate, and other blood test results to ensure the medicine is working safely. Children taking certain other medicines for blood pressure or heart conditions must be on a stable dose before joining the study.

Participants in the study will receive one of the three treatments. The study will monitor changes in their blood potassium levels at various intervals, including 60 minutes, 180 minutes, and 24 hours after treatment. The study will also observe any side effects, heart rhythm issues, or other cardiovascular events that may occur during the treatment period. The goal is to find the best first-line treatment for quickly lowering potassium levels in patients with hyperkalemia.

The trial will involve the use of NovoRapid and Humalog, both of which are forms of insulin, as well as salbutamol in two different formulations: SALBUTAMOL ARROW and SALBUTAMOL VIATRIS. Additionally, glucose will be used in the insulin/dextrose infusion. The study is designed to provide valuable information on the effectiveness and safety of these treatments in managing acute hyperkalemia.

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.

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 study is divided into different phases. Initially, there is a Correction Phase where the main goal is to see if SZC can help achieve normal potassium levels in the blood, known as normokalemia, within a few days. Following this, there is a 28-day Maintenance Phase where the focus is on maintaining these normal potassium levels in children who have already achieved them. Throughout the study, participants will take SZC and have regular check-ups to monitor their potassium levels and overall health.

Participants in the study will be children from birth up to 18 years old who need treatment for hyperkalemia. The study will involve regular visits to monitor the levels of potassium and other substances in the blood. The treatment period can last up to 26 weeks, depending on the needs of the participants. The study aims to provide valuable information on how well SZC works in managing hyperkalemia in children and its safety profile over time.

During the study, participants will be randomly assigned to receive either patiromer or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The trial will monitor the participants’ potassium levels and other health markers over time to see if patiromer helps maintain safe potassium levels and allows patients to continue their RAAS inhibitor therapy. The study will also look at other health factors, such as kidney function and overall quality of life, to understand the broader effects of the treatment.

The trial will last for several months, with regular visits to check on the participants’ health and adjust treatments as needed. The goal is to gather information on how effective and safe patiromer is for managing hyperkalemia in patients with advanced CKD, potentially offering a new way to help these patients maintain their kidney health and treatment regimen.