[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperkalemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperkalemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,67,101,134,164,188,212,234,260,286,315],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100498175","phase-2-patiromer-for-treatment-of-hyperkalaemia-in-children-under-12-years-of-age-100498175",false,"NCT05766839","Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age","A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children Under 12 Years of Age With Hyperkalaemia (EMERALD2)","Inclusion Criteria:\n\n* The following inclusion criteria must be met for each participant:\n* \\- Paediatric participants (\\\u003C12 years of age) with hyperkalaemia at screening.\n* \\- Participant's age should not reach 12 years during the 28 days of the pharmacodynamic\u002Fdose-ranging period.\n* \\- Participant is able to receive regular external feeding and medication, including via tubes, i.e., percutaneous endoscopic gastrostomy (PEG) or entero-gastric feeding tube.\n* \\- At screening\u002Fbaseline, the results from 2 separate and consecutive potassium assessments using the same measurement method (whole blood, plasma, or serum) need to be above the age-appropriate upper limit of normal (ULN).\n* \\- If taking any renin-angiotensin aldosterone system inhibitors (RAASi), beta blockers, fludrocortisone, or diuretic medications, must be on a stable dose for at least 14 days prior to screening.\n* \\- Parent(s) or legally authorised representative(s) or another appropriate person delegated by the legally authorised representatives must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day; accurately and reliably dispense investigational product as directed.\n* \\- Females of childbearing potential must be non-lactating, must have a negative pregnancy test at screening, and must have used an effective, acceptable form of contraception (e.g., abstinence) for at least 1 month before patiromer administration. Females of childbearing potential must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer.\n* \\- If undergoing peritoneal dialysis, participants must be on a stable treatment plan for a minimum of 4 weeks prior to screening, or at least 8 weeks prior to screening if newly initiated on peritoneal dialysis.\n\nExclusion Criteria:\n\n* The following criteria exclude a participant from participating in this trial:\n* \\- Preterm birth infants with \\\u003C37 weeks of gestation cannot be included in Cohort 3.\n* \\- Participants who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.\n* \\- Any of the following renal conditions: maintenance haemodialysis, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes) or a history of acute renal insufficiency in the past 3 months. Note: Chronic kidney disease (CKD) is not excluded.\n* \\- A history of or current diagnosis of a severe gastrointestinal (GI) diagnosis or surgery that could affect GI transit of the drug (delayed gastric emptying), such as a severe swallowing disorder, severe gastroesophageal reflux, uncorrected pyloric stenosis, intussusception, any other intestinal obstruction (e.g., Hirschsprung disease, chronic intestinal pseudo-obstruction, clinically significant postsurgical abdominal adhesions) or any gut-shortening surgical procedure prior to screening. Pre-gastric above-mentioned pathologies may be disregarded in case of existence of a PEG or entero-gastric feeding tube, as the PEG or entero-gastric feeding tube will serve for nutrition and investigational product administration.\n* \\- Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer).\n* \\- Scheduled for kidney transplant procedure during the first 28 days after Day 1.\n* \\- History of sudden infant death in a sibling (only for participants \\\u003C2 years of age at screening).\n* \\- Use of the following medications if doses have not been stable for at least 14 days prior to screening or if doses are anticipated to change during the 4-week pharmacodynamic\u002F\n* dose-ranging period: digoxin, bronchodilators, theophylline, heparins (including low molecular heparins), tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole.\n* \\- Use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer.\n* \\- Known hypersensitivity to patiromer or its components.\n* \\- If the child is being breastfed:\n* a)There is suspicion of current alcohol or substance misuse\u002Fabuse in breastfeeding mother\n* b)The breastfeeding mother is taking potassium supplements\n* Other protocol defined Inclusion\u002FExclusion criteria may apply","ALL","0 Years","11 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.",[27],"Hyperkalemia","RECRUITING","2026-05-29",{"date":31,"type":32},"2026-06-01","ACTUAL",{"date":34,"type":32},"2025-04-06",{"date":36,"type":21},"2030-12-01",{"name":38,"class":39},"Vifor Pharma, Inc.","INDUSTRY",37,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100621405","observational-study-on-the-prevalence-and-risk-factors-of-patients-with-hyperkalaemia-in-brazil-100621405","NCT07370194","Observational Study on the Prevalence and Risk Factors of Patients With Hyperkalaemia in Brazil","Investigating the Impact of Serum Potassium Levels on Prevalence and Risk Factors Associated With Management Strategies for Patients With Hyperkalaemia in Brazilian Clinical Settings: An Observational Study.","HOPE","Inclusion Criteria:\n\n* Participants aged 18 years or older; Pre-existing comorbidities, including: o Heart failure (regardless of phenotype); o Chronic kidney disease (any stage); o Diabetes mellitus; o Systemic arterial hypertension.\n\nExclusion Criteria:\n\n* Diagnosis of advanced malignant neoplasm undergoing palliative treatment; Other advanced diseases with a life expectancy of less than one year; Patients with no information on risk factors for hyperkalaemia (HK).","18 Years",{"count":51,"type":21},6215,"OBSERVATIONAL","This is a descriptive, retrospective study involving patients from private cardiology, nephrology, and dialysis clinics in Brazil who participated in the National Hyperkalaemia Diagnosis Campaign. The study used anonymised data from the Hi Technologies Ltda. database. The objective was to estimate and characterise the prevalence of hyperkalaemia (HK), as well as to analyse the demographic profile, clinical characteristics, risk factors and treatment patterns associated with total blood potassium levels.",[27],[56],"serum potassium levels","2026-05-26",{"date":59,"type":32},"2026-05-27",{"date":61,"type":32},"2026-03-31",{"date":63,"type":21},"2026-09-30",{"name":65,"class":39},"AstraZeneca",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100633221","phase-4-spironolactone-alternate-dosing-vs-finerenone-in-elevated-potassium---k-safety-study-100633221","NCT07523867","Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study","Safety of Finerenone Versus Alternate-Day Spironolactone in Patients With Heart Failure and Diabetic Kidney Disease at High Risk for Hyperkalemia: The SAFE-K Randomized Trial","SAFE-K","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of heart failure, regardless of left ventricular ejection fraction\n* Diagnosis of type 2 diabetes mellitus\n* Diabetic kidney disease, defined by the presence of albuminuria (urinary albumin-to-creatinine ratio ≥ 30 mg\u002Fg)\n* Estimated glomerular filtration rate (eGFR) ≥ 25 mL\u002Fmin\u002F1.73 m²\n* Serum potassium between 5.0 and 5.5 mEq\u002FL at screening\n* Receiving or eligible to receive standard of care therapy for heart failure\n* Ability to provide written informed consent\n* Ability to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Serum potassium \\> 5.5 mEq\u002FL at screening\n* Acute kidney injury at the time of enrollment\n* Symptomatic hypotension or systolic blood pressure \\\u003C 90 mmHg\n* Clinically significant arrhythmias requiring immediate intervention\n* Known hypersensitivity or contraindication to finerenone or spironolactone\n* Use of potassium-sparing diuretics other than the study drugs\n* Pregnancy or breastfeeding\n* Participation in another interventional clinical trial\n* Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures",{"count":76,"type":21},60,[78],"PHASE4","This study evaluates the safety of finerenone compared with alternate-day spironolactone in patients with heart failure and diabetic kidney disease at increased risk of hyperkalemia.\n\nPatients with chronic kidney disease and heart failure often benefit from mineralocorticoid receptor antagonists, but their use is frequently limited by elevated potassium levels. Finerenone has been associated with a lower risk of hyperkalemia in clinical trials, but direct comparisons with spironolactone in high-risk patients are limited.\n\nIn this randomized study, eligible participants will be assigned to receive either finerenone once daily or spironolactone on alternate days, in addition to standard therapy. Patients will be closely monitored during hospitalization and followed for 4 weeks.\n\nThe primary outcome is clinically relevant hyperkalemia, defined by elevated potassium levels or the need to adjust or discontinue treatment due to hyperkalemia. Secondary outcomes include changes in potassium levels, kidney function, and clinical events.\n\nThis study aims to provide practical evidence to guide the safe use of mineralocorticoid receptor antagonists in patients at high risk for hyperkalemia.",[81,82,27],"Heart Failure","Diabetic Kidney Disease",[84,85,86,87,27,88,89],"Finerenone","Spironolactone","Heart Failure Treatment","Chronic Kidney Disease","Mineralocorticoid Receptor Antagonist","Cardiorenal Syndrome","NOT_YET_RECRUITING","2026-05-09",{"date":93,"type":32},"2026-05-13",{"date":95,"type":21},"2026-04",{"date":97,"type":21},"2026-11",{"name":99,"class":100},"Hospital de Messejana Dr. Carlos Alberto Studart Gomes","OTHER_GOV",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":73,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":66},"100630945","safety-of-a-healthy-plant-based-diet-with-higher-potassium-content-compared-to-a-healthy-plant-based-diet-with-limited-potassium-content-in-patients-with-chronic-kidney-disease-a-pilot-study-100630945","NCT07494266","Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study","Säkerheten av en hälsosam växtbaserad Kost Med högre kaliuminnerhåll, jämfört Med en hälsosam växtbaserad Kost Med begränsat kaliuminnehåll Hos Patienter Med Kronisk Njursjukdom: En Pilotstudie","Inclusion Criteria\n\n* Age between 20 and 85 years\n* Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* Normal potassium levels (plasma potassium 3.5-5.3 mmol\u002FL)\n* Not on dialysis\n* Good knowledge of Swedish\n\nExclusion Criteria\n\n* Pregnancy\n* Breastfeeding\n* Kidney transplant\n* Regular use of potassium binders at least 4 days\u002Fweek (e.g. sodium zirconium cyclosilicate, patiromer or sodium polystyrene sulfonate)\n* Regular prescription of daily potassium salts (e.g. potassium chloride)\n* Planned kidney transplant\n* Planned start of dialysis within the next 6 months\n* Allergy to nuts (including peanuts)\n* Mental illness and cognitive impairment that impede understanding of dietary advice\n* Comorbidities that may affect potassium balance (e.g. adrenal insufficiency, inflammatory bowel disease, chronic diarrhoea or colostomy)","20 Years","85 Years",{"count":111,"type":21},30,[113],"NA","For many years, people with moderate to advanced chronic kidney disease (CKD) have been advised to limit their intake of potassium, a mineral found in many foods such as fruit, vegetables, legumes, whole grains, and nuts. The reason for this has been the risk of hyperkalemia, a condition in which the potassium level in the blood becomes too high and can be dangerous. In recent years, however, this view has been questioned. New research suggests that the link between potassium in food and high potassium levels in the blood may not be as clear as previously thought. People who follow a strict potassium-restricted diet experience a lower quality of life and less satisfaction with their dietary treatment. At the same time, they miss out on the health benefits of eating a varied and nutritious diet.\n\nToday, many experts advocate a more individualized approach to potassium intake: instead of generally restricting potassium, the goal should be to maintain normal potassium levels in the blood, while encouraging a healthy diet. However, this message is not always clear in healthcare, and many people therefore continue to avoid potassium-rich foods altogether. The result is that they eat fewer natural ingredients and instead consume more processed and ultra-processed foods. Such foods can be more harmful, partly because they often contain potassium additives that are absorbed effectively by the body and their quantities are not reported in the nutritional label. This \"hidden\" potassium can contribute more to high potassium levels in the blood than the potassium that occurs naturally in plant-based foods. In addition, potassium from whole plant-based foods is absorbed more slowly, partly due to its fiber content.\n\nPlant-based diets may also have other positive effects for people with kidney disease: they can contribute to reduced blood acidity, known as metabolic acidosis, healthier gut flora, lower levels of inflammation, and reduced phosphorus intake. Together, these factors can counteract several of the metabolic complications associated with kidney disease.\n\nIn a previous study, our research group showed that even patients with advanced kidney disease (CKD stage 4-5) and already elevated potassium levels could follow a healthy plant-based diet if they also used a potassium-binding drug (sodium zirconium cyclosilicate, SZC). This enabled them to eat more fruit, vegetables, and legumes, while also experiencing improved quality of life. The current study builds on these results and is planned as a pilot study in which patients with moderate to advanced kidney disease, but who are not yet being treated with dialysis, are assigned to two different dietary strategies for six months:\n\n* Healthy plant-based diet (healthy-PBD): a more liberal and balanced plant-based diet without specific potassium restrictions.\n* Potassium-restricted plant-based diet (restricted-PBD): a traditional plant-based diet with restrictions on potassium-rich foods, according to current standard recommendations.\n\nThe main purpose is to investigate whether the healthy plant-based diet leads to more or more severe cases of hyperkalemia than the restricted diet. Our hypothesis is that potassium levels may increase slightly in the group with a liberal diet, but not to dangerous levels. The study will also examine secondary outcomes, such as quality of life, satisfaction with treatment, and how well patients accept the diet. In addition, taste experiences will be tested with taste strips (sweet, sour, salt, bitter and umami) before and after the intervention in both groups. If this pilot study shows that a healthier and less restrictive diet is safe, it could pave the way for a larger study investigating the long-term metabolic effects of a plant-based diet in kidney care.",[27,116],"Chronic Kidney Disease (Stages 4 and 5)",[118,27,119,120,121,122,123],"Chronic kidney disease","Plant-based diet","Potassium","Patient satisfaction with CKD treatment","RCT","Pilot study","2026-04-23",{"date":126,"type":32},"2026-04-29",{"date":128,"type":21},"2026-04-10",{"date":130,"type":21},"2030-06-30",{"name":132,"class":133},"Karolinska Institutet","OTHER",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":66},"100544234","phase-1-adding-urea-to-the-final-dialysis-fluid-100544234","NCT06366230","Adding Urea to the Final Dialysis Fluid","Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities","Urea dialysate","Inclusion Criteria:\n\n* Serum Urea \\> 120\n* Serum Potassium \\> 5.5 or serum CO2 \\\u003C 15 or need for aggressive dialysis due to toxic ingestion\n* need for dialysis\n\nExclusion Criteria:\n\n* Pediatric\n* need for CRRT",{"count":143,"type":21},20,[145,24],"PHASE1","At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and\u002For fix the metabolic acidosis.",[148,149,27,150],"Dysequilibrium Syndrome","ESRD","Metabolic Acidosis",[149,152,153,120,154],"Urea","Disequilibrium","Acid\u002Fbase","2026-02-09",{"date":157,"type":32},"2026-02-12",{"date":159,"type":32},"2025-09-16",{"date":161,"type":21},"2028-06-30",{"name":163,"class":133},"University of California, San Francisco",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100446240","dietary-potassium-liberalization-in-pre-dialysis-patients-100446240","NCT05090865","Dietary Potassium Liberalization in Pre-Dialysis Patients","Dietary Potassium Liberalization With Fruit and Vegetables Versus Potassium Restriction in People With Chronic Kidney Disease (DK-Lib CKD) Trial","DK-LIB","Inclusion Criteria:\n\n* Male or female, aged 18 years or above\n* Participants who have an estimated glomerular filtration rate between 15 and 45 ml\u002Fmin\u002F1.73m2\n* Serum potassium concentration between 4.5 and 5.5 milliequivalent (mEq)\u002FL\n* Hemoglobin A1c ≤ 11%\n* Systolic and diastolic blood pressure \\<160\u002F100 mmHg\n* Are registered in the multidisciplinary nephrology clinic in Winnipeg\n* Able to communicate in English and provide written informed consent\n\nExclusion Criteria:\n\n* Serum potassium concentration \\> 5.6 mEq\u002FL, anuria, dialysis, or acute kidney injury failure in the 6 months prior to screening\n* Chronic obstructive pulmonary disease that requires the participant to be on oxygen\n* New York Heart Association Class 3-4 Heart symptoms or heart, liver or renal transplant\n* A myocardial infarction or stroke within the last 6 months\n* Unable to consume study treatments or control, such as swallowing or gastro-intestinal issues\n* Currently on potassium binding therapy\n* In the opinion of the investigator any medical condition, uncontrolled systemic disease or concurrent illness that would decrease the study compliance or jeopardize the safety of the participant\n* Female participant who is pregnant or lactating",{"count":111,"type":21},[113],"The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design. Participants will receive home delivery of fruit and vegetables with either higher or lower potassium content in a random order. Clinical chemistry markers from blood and urine samples, blood pressure, physical functioning and health related quality of life will be assessed throughout the duration of the trial. This study will also measure their physical functioning, using a chair stand test. The results of this study could change the dietary recommendations for people with CKD related to potassium.",[87,27],[120,177],"Nutrition","2026-01-14",{"date":180,"type":32},"2026-01-16",{"date":182,"type":32},"2024-01-15",{"date":184,"type":21},"2026-05-31",{"name":186,"class":133},"University of Manitoba",2,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":66},"100535835","phase-4-potassium-correction-for-raas-optimization-in-chronic-kidney-disease-100535835","NCT06256991","Potassium Correction for RAAS Optimization in Chronic Kidney Disease","Potassium Correction for Renin-angiotensin-aldosterone System Optimization in Chronic Kidney Disease","PROMISE","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* CKD stage 3b-4 (eGFR 15-44 mL\u002Fmin\u002F1.73 m2)\n* Albumin-creatinine ratio \\>3 mg\u002Fmmol, or proteinuria \\>0.05g\u002F24u, or protein-creatinine ratio \\> 5mg\u002Fmmol\n* Systolic blood pressure \\>130 mmHg or use of one or more antihypertensive drugs;\n* Serum K+ 4.0-5.0 mmol\u002FL;\n* On sub-maximal dose ACEi\u002FARB\n\nExclusion Criteria:\n\n* prior ACEi\u002FARB dose reduction due to a drop in eGFR by \\>25% in the last year;\n* history of severe hyperkalaemia (\\>6.0 mmol\u002FL) in the last year;\n* pregnancy or breastfeeding\n* life expectancy \\\u003C12 months\n* the use of lithium, potassium-sparing diuretics, potassium supplements, trimethoprim or NSAIDS\n* kidney transplant recipients, or diagnosis of autosomal dominant polycystic kidney disease or other non-glomerular kidney disease",{"count":197,"type":21},44,[78],"The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b\u002F4.\n\nThe main questions it aims to answer are:\n\n* Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in albuminuria and blood pressure?\n* Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in blood pressure?\n\nThe trial contains the following interventions:\n\n* Participants will be switched from their ACEi\u002FARB to a standardised dose of irbesartan (150 mg\u002Fd).\n* During two 12-week study periods, participants will receive either patiromer 8.4 g\u002Fd or placebo. The order of study periods is randomized.\n* At the start of each study period irbesartan will be up-titrated to 300 mg\u002Fd.\n* After 1 and 6 weeks, at both periods, plasma potassium will be measured and the irbesartan dose will be reduced to 150 mg\u002Fd in case plasma potassium exceeds 5.0 mmol\u002FL.\n* At 12 weeks from the start of the study period, the endpoints will be assessed.\n* Between the two study periods, there is a 6-week washout. Irbesartan dose during the wash-out period will be 150mg\u002Fd. After washout, participants will switch from the patiromer arm to the placebo arm or vice versa.",[201,27,202],"Chronic Kidney Diseases","Hypertension","2025-12-12",{"date":205,"type":32},"2025-12-19",{"date":207,"type":32},"2024-04-01",{"date":209,"type":21},"2027-12",{"name":211,"class":133},"University Medical Center Groningen",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":231,"locationsCount":233},"100612263","phase-3-a-two-part-phase-3-study-evaluating-the-efficacy-and-safety-of-ws016-for-the-treatment-of-hyperkalemia-100612263","NCT07251309","A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of WS016 in Patients With Hyperkalemia","Inclusion Criteria:\n\n* Adults (male or female) aged 18 years and older;\n* Participants with a serum potassium concentration \\>5.0 mmol\u002FL and ≤6.5 mmol\u002FL (serum potassium concentration will be measured using the i-STAT portable biochemical analyzer in screening period);\n* Participants who have negative pregnancy test result at screening and ensure the use of contraception during the trial;\n* Participants who understand and voluntarily sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Participants who have a history of severe drug allergy, or are definitely allergic to the investigational product or its ingredients;\n* Participants who have pseudohyperkalemia, such as serum potassium increasing caused by hemolysis of blood samples due to improper blood collection methods (such as too tight pressure pulse band banding, too heavy local rubbing, repeated fist clenching-loosening hands), hemolysis of blood samples due to difficulty in venipuncture or trauma, and severe leukocytosis (\\>50 × 10\\^9\u002FL) or thrombocytosis (\\>500 × 10\\^9\u002FL);\n* Participants with acute hyperkalemia caused by conditions such as tumor lysis syndrome or hemolysis and so on;\n* Participants suffering from severe cerebrovascular diseases, such as cerebral infarction or cerebral hemorrhagic disease, with language disorder or unresponsiveness, or severely blocked limb movement;\n* Participants who have suffered from myocardial infarction, or have undergone interventional cardiac procedures or coronary artery bypass grafting for coronary atherosclerotic heart disease within 3 months prior to screening; or participants who have heart failure and are in cardiac function class IV (New York Heart Association, NYHA classification criteria) at screening;\n* Participants with cardiac arrhythmia requiring urgent treatment at screening, such as ventricular tachycardia, ventricular fibrillation, II-III degree atrioventricular block, severe bradycardia (heart rate \\\u003C40 bpm), or participants with significant prolongation of PR interval (PR interval prolonged to more than 0.25 seconds in the absence of pre-existing atrioventricular block), decrease or disappearance of P wave amplitude, and widening of QRS wave (widening to more than 0.14 seconds in the absence of pre-existing bundle branch block) indicated by the electrocardiogram at screening;\n* Participants who have previously undergone major gastrointestinal surgery such as subtotal gastrectomy, short bowel syndrome and other diseases affecting the normal peristalsis of the gastrointestinal tract; or participants with intractable constipation;\n* Participants who have received treatment with polypropylene exchange resin or sodium zirconium cyclosilicate and other similar drugs within 3 days before screening;\n* Participants who participated in other clinical trials of drugs or devices not approved for marketing within 3 months prior to the first dose;\n* Participants who are receiving dialysis;\n* Participants with severe hepatic impairment: serum alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal;\n* Participants who are unable to complete this part of the trial as assessed by the investigator due to any other disease or psychiatric condition; or participants whose participation in the trial is assessed by the investigator as having a risk that far outweighs the benefit.",{"count":220,"type":21},420,[222],"PHASE3","This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase (MP). Part B (open-label extension, OLE) is an open-label, 11-month extension study carried out in participants who come from Part A and meet certain inclusion criteria.",[27],"2025-11-18",{"date":227,"type":32},"2025-11-26",{"date":229,"type":32},"2024-12-23",{"date":97,"type":21},{"name":232,"class":39},"Waterstone Pharmaceutical (Wuhan) Co., LTD.",50,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":241,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":256,"leadSponsor":258,"locationsCount":66},"100609089","ak-guard-pilot-study-in-chronic-kidney-disease-outpatient-diagnostic-accuracy-and-remote-monitoring-100609089","NCT07210021","AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring","Diagnostic Accuracy, Usability, Patient Compliance, and System Reliability of the AK+ Guard™ ECG Application for Hyperkalemia Prediction in Ambulatory Chronic Kidney Disease Patients (Outpatient and Remote Monitoring Arms)","Inclusion Criteria:\n\n(Arm 2A - Outpatient Diagnostic Accuracy)\n\n* Age 22 years or older\n* CKD stages III-IV managed at Central Jersey Kidney Care outpatient clinic\n* Scheduled outpatient serum potassium laboratory test\n* On RAASi therapy or documented hyperkalemia (K+ ≥ 5.5 mmol\u002FL) within the past 12 months\n* Able to provide written informed consent\n\n(Arm 2B - Remote Patient Monitoring)\n\n* Completion of Arm 2A visit\n* Owns an iPhone compatible with the study application\n\nExclusion Criteria (Both arms):\n\n* Age 21 years or younger\n* Pacemaker or implantable cardioverter defibrillator\n* Pre existing Left Bundle Branch Block (LBBB), Right Bundle Branch Block (RBBB), Intraventricular Conduction Delay (IVCD), or clinically significant hypocalcemia\n* Potassium lowering treatment administered before Lead I ECG acquisition\n* Trauma, acute events, or active interventions altering potassium homeostasis\n* Physical limitation precluding ECG acquisition","22 Years",{"count":233,"type":21},"The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol\u002FL) in adults with chronic kidney disease (CKD).\n\nStudy objectives are:\n\n* Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol\u002FL) at the time of an outpatient laboratory draw.\n* Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.",[27,245],"Chronic Kidney Disease (Stage 3-4)",[247,248,249,250,251],"hyperkalemia","ambulatory CKD","CKD","chronic kidney disease","ECG","2025-10-14",{"date":254,"type":32},"2025-10-16",{"date":252,"type":32},{"date":257,"type":21},"2025-11-28",{"name":259,"class":39},"AccurKardia, Inc.",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":66},"100588362","prevalence-and-risk-factors-of-hyperkalemia-in-non-dialysis-chronic-kidney-disease-patients-in-community-100588362","NCT06940414","Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community","Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in a Community-Based Primary Care Setting","Inclusion Criteria:\n\n* Aged 18 years or older with stable vital signs, specifically defined as:\n\n  1. Body temperature: 36.0°C-38.0°C;\n  2. Pulse: 50-120 beats\u002Fmin;\n  3. Respiratory rate: 10-24 breaths\u002Fmin;\n  4. Blood pressure: Systolic blood pressure ≥90 mmHg and diastolic blood pressure ≥60 mmHg.\n* Willing to participate in the study and sign the informed consent form.\n* Hematocrit (Hct) level between 25% and 60%.\n* Confirmed diagnosis of chronic kidney disease (CKD).\n\nExclusion Criteria:\n\n* Patients in the unstable phase of acute cardiovascular or cerebrovascular diseases (e.g., acute cerebral infarction, cerebral hemorrhage, or acute coronary syndrome).\n* Patients in the unstable phase of severe acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic coma).\n* Patients currently in the acute kidney injury (AKI) stage.\n* Patients who have started renal replacement therapy.\n* Pregnant or breastfeeding women.\n* Patients currently participating in or who have participated in other clinical trials within the past six months.\n* Patients unable to understand verbal or written instructions, including informed consent content.\n* Patients unable to cooperate with the study procedures.\n* Other conditions deemed unsuitable for participation in this clinical trial by the investigator.",{"count":268,"type":21},1890,"The goal of this observational study is to investigate the prevalence and risk factors of hyperkalemia in community-based non-dialysis chronic kidney disease (CKD) patients. The main questions it aims to answer are:\n\n1. What is the prevalence of hyperkalemia in non-dialysis CKD patients in a primary care setting?\n2. What are the key risk factors influencing the occurrence of hyperkalemia in this population? Researchers will collect clinical and demographic data from participants across 18 community health centers and use both point-of-care testing (POCT) and laboratory-based methods to measure serum potassium levels and related parameters.\n\nParticipants will:\n\n1. Provide blood samples for POCT and laboratory testing.\n2. Participate in interviews or questionnaires to gather clinical and lifestyle information.\n\nThe findings will be used to construct a risk prediction model for hyperkalemia, aiming to optimize screening pathways and improve disease management strategies in primary care.",[27,271],"Chronic Kidney Disease(CKD)",[27,87,273,274,275,276],"Community-Based","Non-Dialysis","Prevalence","Eaglenos POCT System","2025-07-08",{"date":279,"type":32},"2025-07-11",{"date":281,"type":32},"2025-04-28",{"date":283,"type":21},"2025-09-30",{"name":285,"class":100},"Xiujuan Zang",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":302,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":4},"100572662","phase-4-the-cardioprotective-effects-of-improving-potassium-variability-in-maintenance-hemodialysis-patients-100572662","NCT06736184","the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients","A Prospective Multicenter Randomized Controlled Trial on the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients","Inclusion Criteria:\n\n1. Age 18-75 years old;\n2. Maintenance hemodialysis ≥3 months;\n3. Serum potassium ≥5.0mmol\u002FL and ≤8mmol\u002FL before dialysis;\n4. Have independent ability;\n5. Complete clinical baseline data.\n\nExclusion Criteria:\n\n1. Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;\n2. Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;\n3. Unable to cooperate with the researcher due to mental reasons;\n4. If the duration of dialysis is less than 4 hours, severe infection;\n5. Patients with malignant tumors or major mental disorders;\n\n6, except primary cardiomyopathy;\n\n7\\. Severe constipation, intestinal obstruction, etc.\n\n8\\. other investigators considered that enrollment was not recommended.","75 Years",{"count":295,"type":21},100,[78],"The management of serum potassium in maintenance hemodialysis（MHD ）patients is one of the hot topics at present. In order to control hyperkalemia in dialysis patients, the use of hypokalemic dialysate is the most important measure to reduce potassium. This measure effectively reduces serum potassium, but increases the risk of hypokalemia after dialysis, which increases the risk of all-cause death in patients. Hyperkalemia and hypokalemia during and at the end of dialysis are important factors for arrhythmia and death in MHD patients. Due to the intermittent nature of hemodialysis treatment, MHD patients often experience frequent fluctuations in serum potassium, which is a potential risk factor for poor prognosis of MHD patients. Serum potassium variability can better reflect the potassium homeostasis in MHD patients. In addition to hyperkalemia and hypokalemia, serum potassium variability is a potential risk factor affecting the prognosis of MHD patients. At present, there are few studies on the effect of improving serum potassium variability on cardiovascular complications, especially multi-center randomized controlled trials. In this study, sodium zirconium cyclosilicate was used to control hyperkalemia before dialysis and increase potassium concentration in dialysate, so as to reduce the risk of hypokalemia after dialysis, and to verify whether improving serum potassium variability can reduce myocardial injury in hemodialysis patients.",[299,300,27,301],"Chronic Kidney Disease on Hemodialysis","Hypokalemia","Myocardial Injury",[303,304,305],"maintenance hemodialysis","Potassium Variability","Myocardial injury","2024-12-12",{"date":308,"type":32},"2024-12-16",{"date":310,"type":21},"2025-03-01",{"date":312,"type":21},"2026-12-31",{"name":314,"class":133},"Qianfoshan Hospital",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":322,"targetDuration":324,"studyType":52,"phases":4,"briefSummary":325,"conditions":326,"keywords":329,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":66},"100564931","chronic-kidney-disease-hyperkalemia-and-echocardiographic-changes-100564931","NCT06635590","Chronic Kidney Disease, Hyperkalemia and Echocardiographic Changes","The Impact of Hyperkalemia-Induced ECG and ECHO Findings on Early and Late Mortality in Patients With Chronic Kidney Disease","Inclusion Criteria:\n\n1. Patients over 18 years old\n2. Chronic kidney disease patients with eGFR \\< 60 mL\u002Fmin\u002F1.73 m²\n3. Patients with hyperkalemia detected in the emergency department\n4. Patients willing to participate in the study and who sign the consent form\n\nExclusion Criteria:\n\n1. Patients under 18 years old\n2. Patients who do not wish to participate in the study\n3. Patients without chronic kidney damage\n4. Patients without detected hyperkalemia\n5. Patients needing cardiopulmonary resuscitation due to hyperkalemia",{"count":323,"type":21},40,"30 Days","Patients with CKD ( eGFR \\< \\<60 mL\u002Fmin\u002F1,73 m2) presenting to emergency department with isolated hyperkalemia will be study population. Pre and post treatment ECG and echocardiographic findings will be recorded. Investigator will not intervene with the treatment decision of responsible physician and will not delay any intervetion or treatment for the sake of study.\n\nData will be compared in terms of ECHO and ECG findings depending on hyperkalemia level and response to treatment.",[327,27,328],"Chronic Kidney Disease (CKD)","Hemodialysis",[330,251,250,247],"echocardiography","2024-10-08",{"date":333,"type":32},"2024-10-10",{"date":335,"type":32},"2024-02-01",{"date":337,"type":21},"2025-02-01",{"name":339,"class":133},"Saglik Bilimleri Universitesi"]