Hyperkalemia

Researchers are evaluating the drug WS016 in adults with hyperkalemia, a condition characterized by elevated potassium levels in the blood. This Phase 3 clinical trial aims to study the effectiveness and safety of WS016 through a two-part design including a corrective phase to quickly reduce potassium levels and a maintenance phase to keep potassium normal. An open-label extension phase is also included to assess longer-term treatment effects. In Part A, participants are first randomized to receive either oral WS016 (12g) or placebo three times daily for 48 hours during the corrective phase. Those who achieve normal potassium levels are then re-randomized to receive WS016 at doses of 6g, 12g, or 18g, or placebo once daily for 28 days in the maintenance phase. Part B is an open-label extension lasting 11 months, where participants receive WS016 starting at 12g daily, with dose adjustments based on potassium levels. Participants will have regular blood tests to monitor serum potassium and other health measures throughout the study. Researchers will track potassium levels during the maintenance phase and corrective phase to assess drug effects. Safety and tolerability will be monitored, and participants completing or discontinuing the maintenance phase may continue treatment in the extension phase. Overall participation can last up to nearly a year depending on enrollment in Part B.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Patients with advanced kidney failure often face serious issues like high potassium levels, severe acidosis, and very high blood urea nitrogen (BUN) levels. These patients require aggressive dialysis to manage these problems, but rapid lowering of BUN can cause a dangerous condition called disequilibrium syndrome. This research explores adding urea to the dialysis fluid to prevent this rapid BUN decrease while still addressing potassium and acidosis concerns. The study uses Ure-Na 15 gram tablets to add urea to the dialysis fluid. The amount of urea added is carefully calculated based on the dialysis system and the patient's serum urea levels to keep the dialysate urea concentration slightly lower than the patient's serum level. This intervention is applied during the first one to three dialysis treatments as needed, and patients who receive this urea-added dialysate are closely monitored. Participants will have their laboratory values, vital signs, and symptoms checked frequently during and after dialysis. Key outcomes measured include the occurrence of disequilibrium syndrome within 24 hours after dialysis, serum potassium and CO2 levels every six hours for 24 hours post-dialysis, and serum BUN levels twice daily for three days. This monitoring ensures the safety and effectiveness of the urea addition approach throughout the study duration.

Researchers are evaluating the AK+ Guard21 software, an investigational medical device designed to detect moderate to severe hyperkalemia (high potassium levels) in adults with chronic kidney disease (CKD) stages III-IV. This observational pilot study aims to assess the diagnostic accuracy of the software in an outpatient setting and its usability and reliability during daily remote monitoring. The study focuses on adults at risk of hyperkalemia, including those on specific kidney-related therapies, by analyzing Lead I ECG data from standard or wearable devices. The study includes two arms: Arm 2A involves participants scheduled for routine outpatient potassium blood tests who will have ECGs recorded using three devices (12-lead ECG, Apple Watch, HeartBeam). The software's diagnostic performance for detecting high potassium is compared to lab results. Arm 2B includes a subset of these participants who agree to use the Apple Watch and study app for daily ECG recordings at home for up to four weeks. Participants also complete weekly surveys and may return for confirmatory lab tests if high potassium is indicated. Participants will have ECGs collected and compared to blood potassium levels to evaluate sensitivity, specificity, and other diagnostic measures. During the remote monitoring phase, researchers will track daily compliance, data completeness, and system reliability, including app performance and user experience through surveys. The study measures include diagnostic accuracy at baseline and usability scores after four weeks. The total participation duration varies with the arm, including up to four weeks of remote monitoring.

Researchers are studying sodium zirconium cyclosilicate (SZC) to evaluate its safety, effectiveness, and tolerability for treating hyperkalaemia in children under 18 years old. This phase 3, international, open-label study will enroll about 140 children in multiple age groups, starting with those aged 6 to under 12 years and 12 to under 18 years, with plans to include younger children based on safety data. The study aims to see how well SZC can correct and maintain normal potassium levels in children with this condition. Treatment includes three phases: a Correction Phase (CP), a Maintenance Phase (MP), and a Long-Term Maintenance Phase (LTMP). In the CP, participants receive a fixed oral dose of SZC three times daily for up to 3 days until potassium levels normalize. Doses are adjusted by body weight and may increase based on safety monitoring. Those who achieve normal potassium enter the MP, receiving daily SZC for 28 days with dose adjustments as needed. Participants may continue into the LTMP for ongoing treatment and monthly visits if they meet certain criteria. Participants will have regular assessments including blood tests for potassium and other electrolytes, urine tests, ECG monitoring, and evaluation of safety and tolerability throughout all study phases. Researchers will track potassium levels to assess correction and maintenance, as well as measure related hormones and kidney function markers. The total study duration is about 28 weeks, including a 1-week safety follow-up after the last dose. The study is conducted at approximately 46 sites across several countries.

This research investigates patients with chronic kidney disease (CKD) who have an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² and present to the emergency department with isolated high potassium levels (hyperkalemia). The study aims to examine electrocardiogram (ECG) and echocardiography (ECHO) findings in these patients and their association with early and late mortality. Researchers will compare these findings to existing literature to better understand the cardiac effects of hyperkalemia in CKD patients. Participants will form a single group of patients diagnosed with hyperkalemia. Blood samples will be taken to measure potassium levels, followed by ECG and ECHO tests before and after treatment. The ECHO is performed by an experienced physician who is not involved in treatment decisions. The study does not interfere with any medical interventions, which remain under the care of the responsible physician. Throughout the study, data from ECG, ECHO, and laboratory tests will be collected and analyzed. Mortality will be tracked at 24 hours, 7 days, and 30 days after enrollment, excluding other causes of death. The main outcome is to observe changes in echocardiographic findings over 30 days. This study also explores the potential link between cardiac imaging changes due to hyperkalemia and patient survival, offering insight into the usefulness of combined ECG and ECHO monitoring.

Researchers are investigating how the potassium content in fruits and vegetables affects blood potassium levels in people with Chronic Kidney Disease (CKD). The study aims to provide high-quality evidence to guide dietary potassium recommendations, which currently rely on low-quality data. This research also explores whether a diet higher in potassium from fruits and vegetables might improve quality of life for people with CKD. In this 16-week randomized crossover trial, participants will receive deliveries of fruits and vegetables with either higher or lower potassium content in a random order. Each treatment period lasts 6 weeks, separated by a 2-week washout period. During each period, participants will have a dietary counseling session with a registered dietitian to help incorporate the assigned fruits and vegetables into their regular diet. The potassium-rich foods will aim for about 2000 mg of potassium daily from the delivered produce, while the lower potassium foods will provide less than 500 mg daily. Participants will be monitored throughout the trial with blood and urine tests to measure potassium and other markers, blood pressure checks, and assessments of physical function using a chair stand test. Quality of life related to physical function will also be evaluated. The main outcome is the change in blood potassium levels between the two treatment periods. This study will last about 16 weeks and may influence future dietary advice for people with CKD regarding potassium intake.

Researchers are examining the prevalence and characteristics of hyperkalaemia in adults who have heart failure, diabetes, chronic kidney disease, or high blood pressure. This observational study involves patients from private cardiology, nephrology, and dialysis clinics in Brazil who participated in a national campaign for diagnosing hyperkalaemia using point-of-care testing. The study uses anonymized data to explore how common hyperkalaemia is and what demographic and clinical factors are linked to it. The study analyzes anonymized records collected during consultations between April and November 2025. It focuses on adults aged 18 or older of all genders who have the specified health conditions and attended selected clinics. The investigation reviews treatment patterns and risk factors related to blood potassium levels without introducing any new interventions or treatments. Participants' medical histories and potassium test results are reviewed to assess the prevalence and clinical profile of hyperkalaemia over about one year. Researchers will evaluate epidemiological data and the practical and social impact of the condition. The study does not involve active treatment but gathers important health information to better understand hyperkalaemia in clinical settings.

This trial studies patients with end-stage kidney disease who are on chronic dialysis therapy and face the challenge of managing high potassium levels (hyperkalemia). It aims to evaluate whether the oral potassium binder patiromer can help reduce or remove the need for strict potassium dietary restrictions without increasing the risk of hyperkalemia. This phase III, randomized, double-blind, placebo-controlled study will explore how patiromer affects diet flexibility and health-related quality of life in these patients. Participants will be randomly assigned to receive either patiromer or a placebo daily for three months. The medication is taken every morning and is designed to lower potassium levels by binding potassium in the gut, exchanging it for calcium. The study controls for the number of dialysis sessions per week (two versus three) and carefully monitors how the treatment allows adjustments in potassium diet restrictions. Both groups will follow the same schedule, with medication separated by at least three hours from other oral drugs. Throughout the 12-week study, participants will have their serum potassium levels checked before each dialysis session. Researchers will monitor the safety and effectiveness of patiromer in maintaining potassium levels within a normal range while potentially improving diet and quality of life. The study includes careful tracking of side effects and overall health, aiming to find better treatment options for dialysis patients. Total participation lasts for three months of treatment with regular clinical assessments.

Researchers are evaluating the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years old with hyperkalaemia, a condition involving high potassium levels in the blood. This Phase 2, open-label study aims to better understand how patiromer works in this young population and to monitor any side effects or safety concerns. The study involves a 4-week pharmacodynamic and dose-ranging period divided into three age cohorts: children aged 6 to less than 12 years, 2 to less than 6 years, and 0 to less than 2 years. In the youngest cohort, participants are further grouped into those aged 0 to less than 6 months and 6 to less than 24 months. Patiromer will be given once daily, with dosing adjusted by age, and for the youngest participants, the daily dose might be split. During the study, participants will have regular potassium level assessments and various laboratory tests, including chemistry and hematology evaluations, as well as monitoring of heart rate, blood pressure, body temperature, and ECG readings. Researchers will track any treatment-emergent or serious adverse events up to 54 weeks in an extended part of the study. The primary measurement is the change in potassium levels from baseline to Day 28. Follow-up and safety evaluations continue throughout the study duration, which may last up to 52 weeks for some assessments.