[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperkalaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperkalaemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100348179","phase-3-an-open-label-study-to-assess-safety-and-efficacy-of-szc-in-paediatric-patients-with-hyperkalaemia-100348179",false,"NCT03813407","An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia","PEDZ-K","Inclusion Criteria:\n\n1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate)\n2. Female or male from birth to \\\u003C 18 years of age (for the study duration).\n3. Participants (including those receiving a stable peritoneal dialysis regimen for a minimum of 2 months) requiring long-term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort ≥ 2 years, and participants requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort \\\u003C 2 years.\n4. Participants must meet the following criteria for hyperkalaemia: Please refer to the Table 6 in the protocol.\n5. Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening: a. For participants aged 0 to ≤ 3 days after birth: \\\u003C 450 ms b. For participants aged \\>3 days to \\\u003C 12 years: \\\u003C 440 ms c. For participants aged ≥ 12 to \\\u003C 18 years: \\\u003C 450 ms (male), \\\u003C 460 ms (female) All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct.\n6. Ability to have repeated blood draws or effective venous catheterisation.\n7. Females of childbearing potential (defined as a female with potential of becoming pregnant who has experienced her menarche) must have a negative pregnancy test within one day prior to the first dose of SZC on CP Study Day 1 and sexually active females of childbearing potential must be using 2 forms of medically acceptable contraception with at least one being a barrier method\n8. Optional open-label, LTMP only:\n\n   1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate) to take part in the LTMP.\n   2. Participants who are normokalaemic at the end of MP or hyperkalaemic and not on maximum dose.\n   3. Participants who would benefit from long-term treatment for their hyperkalaemia, as judged by the Investigator.\n\nExclusion Criteria:\n\n1. Neonates with a gestational age \\\u003C 37 weeks at birth or a birth weight \\\u003C 2500 g.\n2. Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis).\n3. Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.\n4. Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns. 5. Participants with hyperkalaemia due to a secondary cause, such as dehydration, excessive use of K+ supplements, or drug use (eg, beta-adrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications).\n\n6\\. Participants with transient iatrogenic hyperkalaemia (eg, due to treatment with tacrolimus).\n\n7\\. Participants treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.\n\n8\\. Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE™), or patiromer within the last 4 days prior to first dose of study treatment.\n\n9\\. Participants with a life expectancy of less than 3 months. 10. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.\n\n11\\. Presence of any condition which, in the opinion of the Investigator, places the participant at undue risk or potentially jeopardises the quality of the data to be generated. 12. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.\n\n13\\. Participants with cardiac arrhythmias that require immediate treatment. 14. Participants with a family history of long QT syndrome. 15. Participants on haemodialysis. 16. Participants with a history of bowel obstruction. 17. Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection).\n\n18\\. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n\n19\\. Previous treatment with SZC. 20. Treatment with a drug or device within the last 30 days prior to first dose of study treatment that has not received regulatory approval at the time of study entry.\n\n21\\. Previous enrolment in the present study. 22. Females who are pregnant, breastfeeding, or planning to become pregnant. 23. Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 24. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection) the participant cannot be enrolled in the study.","ALL","0 Years","18 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children \\\u003C18 years of age. Approximately 140 participants will enter CP at approximately 46 sites in locations including but not limited to Europe and North America for this study. Treatment will include 3 phases: the CP, MP, and LTMP. Enrolment will start in 2 cohorts, ages 6 to \\\u003C 12 years and 12 to \\\u003C 18 years. After review of accumulated data, the independent Data Monitoring Committee (iDMC) will recommend whether to open enrolment in the ages 2 to \\\u003C 6 years cohort and later in the ages 0 to \\\u003C 2 years cohort. All eligible participants with hyperkalaemia will enter an open-label Correction Phase (CP) receiving a fixed dose of SZC three times daily (TID) for up to 3 days until normokalaemia is achieved. Within each age cohorts 2 to \\\u003C 18 years, initial participants will be allocated to the dose level (DL) based on body weight equivalent to an adult 5 g TID. After recommendation of higher DLs by the iDMC, subsequent participants may be allocated in the CP to on body weight equivalent to an adult 10 g TID and then potentially on body weight equivalent to an adult 15 g TID. All participants in the ages 0 to \\\u003C 2 years cohort will be assigned to the same DL which will be decided based on data from older age cohorts. Participants who successfully achieve normokalaemia in the CP will enter a 28-day open-label Maintenance Phase (MP), which will be initiated with once daily administration of the dose received TID in the CP. During MP, the Investigator is able to titrate the dose up or down in the range 2.5 g to 15 g body weight equivalent to maintain normokalaemia. For participants who, at the end of MP, are normokalaemic or hyperkalaemic without being on maximum dose, the MP is followed by the option to continue the study in a long term maintenance phase (LTMP) where the same titration regimen is used as in MP",[27],"Hyperkalaemia",[29,30],"sodium zirconium cyclosilicate","Hyperkalaemia in children","RECRUITING","2026-06-12",{"date":34,"type":35},"2026-06-15","ACTUAL",{"date":37,"type":35},"2019-04-02",{"date":39,"type":21},"2030-02-21",{"name":41,"class":42},"AstraZeneca","INDUSTRY",70,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100616601","ai-enabled-ecg-stratification-and-timing-of-potassium-lowering-therapy-in-patients-with-hyperkalemia-a-target-trial-emulation-study-100616601","NCT07307729","AI-Enabled ECG Stratification and Timing of Potassium-Lowering Therapy in Patients With Hyperkalemia: A Target Trial Emulation Study","AIDE-K","Inclusion Criteria:\n\n1. patients visit to emergency department\n2. serum potassium ≥5.5 mEq\u002FL\n3. had a standard 12-lead ECG performed within 1 hour of the qualifying potassium measurement\n\nExclusion Criteria:\n\n1. potassium-lowering therapy administered before the index blood draw\n2. no potassium-lowering therapy initiated within 4 hours after the index draw\n3. duplicate encounters\n4. missing key covariates",{"count":52,"type":21},5000,[54],"NA","Hyperkalemia is a common and potentially life-threatening electrolyte disorder, yet there is limited evidence guiding the optimal timing of potassium-lowering therapy in routine clinical practice. Although electrocardiographic (ECG) abnormalities are recommended to inform treatment decisions, such findings are often subtle and difficult to recognize consistently by clinicians.\n\nThis study aims to emulate a target trial to evaluate the association between the timing of potassium-lowering therapy (timely versus delayed initiation) and short-term mortality among patients with laboratory-confirmed hyperkalemia presenting to the emergency department. In addition, the study examines whether artificial intelligence-enabled ECG (AI-ECG) stratification identifies patient subgroups that may differentially benefit from earlier treatment.\n\nUsing observational electronic health record data from multiple healthcare systems, including publicly available critical care databases and institutionally governed hospital datasets, treatment strategies are compared using causal inference methods designed to approximate randomized assignment. The primary outcome is 90-day all-cause mortality.\n\nThe results of this study are intended to inform clinical decision-making regarding treatment timing in hyperkalemia and to evaluate the potential role of AI-ECG as a risk stratification tool in real-world settings.",[27],[58,59,60,61,62,63],"artificial intelligence","electrocardiogram","emergency department","hyperkalemia","potassium","treatment","NOT_YET_RECRUITING","2025-12-15",{"date":67,"type":35},"2025-12-29",{"date":69,"type":21},"2026-01-01",{"date":71,"type":21},"2026-03-31",{"name":73,"class":74},"National Defense Medical Center, Taiwan","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100582051","phase-3-patiromer-and-diethrqol-in-chronic-dialysis-100582051","NCT06858280","Patiromer and Diet\u002FhrQoL in Chronic Dialysis","Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial","PRINCE","Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):\n\n* More than 18-year-old\n* Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD\n* Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq\u002FL confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia\n* Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics\n* On standardized and stable (moderately or strictly restricted) low-potassium diet\n* Compliance with recommended diet\n* Written informed consent\n\nExclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):\n\n* Hyperkalemia (pre-dialysis potassium \\>5.5 mEq\u002FL during the long interdialytic period)\n* Hypomagnesemia (serum magnesium \\\u003C1.7 mg\u002FdL)\n* Hypercalcemia (serum calcium \\>10.5mg\u002Fdl)\n* Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.)\n* Ongoing treatment with potassium-sparing diuretics\n* Pre-dialysis potassium \\\u003C4.0 mEq\u002FL during the long interdialytic period\n* One or two weekly dialysis session\n* Poor compliance to prescribed potassium-restricted diet\n* History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders\n* Previous history of cardiac arrhythmias potentially related to hypokalemia\n* Known hypersensitivity to the active ingredient or any of the excipients of the study drug\n* Inability to fully understand the potential risks and benefits related to study participation\n* Concomitance of clinical conditions that could jeopardize the completion of the treatment period and\u002For confound data interpretation including:\n* Cancer (except non-metastatic cutaneous cancers)\n* Active systemic autoimmune diseases\n* Concomitant treatment with steroids or any other immunosuppressive agent\n* Severe\u002Funstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months\n* Refractory severe hypertension (BP \\>180\u002F100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications)\n* Known to be positive for human immunodeficiency virus\n* Drug or alcohol abuse\n* Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment\n* Intention to donate ova or sperm over the same period\n* Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1\\_updated.pdf)\n* Involvement in the study planning and\u002For conduct\n* Participation in another clinical study with an investigational product during the last month",{"count":84,"type":21},40,[24],"This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.",[27,88,89],"Chronic Kidney Disease Stage 3 and 4","Dietary Intervention","2025-08-27",{"date":92,"type":35},"2025-09-04",{"date":94,"type":35},"2025-07-08",{"date":96,"type":21},"2026-07",{"name":98,"class":74},"Mario Negri Institute for Pharmacological Research",1]