[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperphosphatemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperphosphatemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,60,111,142,174],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053390","phase-2-a-study-to-evaluate-safety-tolerability-and-efficacy-of-ap306-at-fixed-doses-in-dialysis-participants-with-hyperphosphatemia-100053390",false,"NCT06712654","A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dose AP306 in Participants With Hyperphosphatemia Receiving Maintenance Hemodialysis","Important Inclusion Criteria:\n\n* Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study\n* Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per week for at least 12 weeks before signing the ICF, and does not plan to change in the study\n* Who has a blood phosphate level within the study-required range\n* Who has a dialysis adequacy, assessed by single pooled Kt\u002FV (SpKt\u002FV, estimated with blood urea) ≥1.20, at screening or any documented value ≥1.20 within 12 weeks prior to signing the ICF\n* If the participant is receiving etelcalcetide, their doses must be unchanged for at least 4 weeks prior to signing the ICF\n* If the participant is receiving any of the following therapies, their doses are stable for at least 14 days prior to signing the ICF: phosphate-lowering products other than tenapanor or phosphate binders, active vitamin D and analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors\n* Agreement to use highly effective contraception for women of childbearing potentially and non-sterile sexually active males throughout the study and for 90 days after the final dose of study drug\n\nImportant Exclusion Criteria:\n\n* Pregnant or breastfeeding\n* Scheduled for a living donor kidney transplant in the next 6 months, planned change to peritoneal dialysis or home hemodialysis in the study; planned relocation to another dialysis center in the study\n* Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study\n* Blood calcium or blood intact parathyroid hormone abnormality\n* Adequate organ and bone marrow function\n* Acute hepatitis or significant chronic liver disease\n* Any clinically significant GI disorders within 4 weeks prior to signing the ICF; or any history of gastrectomy; or any GI tract surgery (excluding appendectomy and polypectomy), within 12 weeks of signing the ICF\n* Uncontrolled hypertension\n* Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to signing the ICF\n* Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test\n* Any clinically significant active infection or infestation or any treatment with systemic antimicrobial treatment within 2 weeks prior to signing the ICF\n* History or presence of malignancy within 3 years prior to signing the ICF, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer\n* Taking moderate or strong cytochrome P450 (CYP) 3A inhibitors within 2 weeks or 5 half-lives, whichever is longer, prior to signing the ICF (topical use is allowed)\n* Treatment with any investigational medication or medical device within 30 days prior to signing the ICF\n* Life expectancy less than 12 months","ALL","18 Years",{"count":19,"type":20},168,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.",[26,27,28],"Hyperphosphatemia","Chronic Kidney Disease Requiring Chronic Dialysis","End Stage Renal Disease on Dialysis",[30,31,32,33],"AP306","AP-306","EOS789","pan-phosphate transporter inhibitor","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-06-01",{"date":42,"type":20},"2027-03-31",{"name":44,"class":45},"R1 Therapeutics","INDUSTRY",31,{"id":48,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":24,"conditions":51,"keywords":52,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":59},"100570854",{"count":19,"type":20},[23],[26,27,28],[30,31,32,33],"2026-06-26",{"date":55,"type":38},"2026-06-29",{"date":40,"type":38},{"date":42,"type":20},{"name":44,"class":45},30,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":16,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"0 Years","20 Years",{"count":72,"type":20},5000,"OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[76,77,78,79,80,26,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":102,"type":38},"2026-04-06",{"date":104,"type":38},"2020-03-05",{"date":106,"type":20},"2027-07",{"name":108,"class":109},"Duke University","OTHER",51,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100587829","phase-3-a-study-of-a-novel-iron-based-phosphate-binder-ap301-in-patients-with-hyperphosphatemia-in-the-us-and-china-100587829","NCT06933472","A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China","A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia","RESPOND-2","Key Inclusion Criteria:\n\n* Provision of signed and dated ICF\n* Age ≥ 12 years when signing the ICF\n* Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study\n* For HD patients, spKt\u002FV ≥ 1.2; for PD patients, total Kt\u002FV ≥ 1.7\u002Fweek\n* Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:\n\n  1. Screening: 1.13 mmol\u002FL (3.5 mg\u002FdL) ≤ serum phosphate \\\u003C 2.58 mmol\u002FL (8.0 mg\u002FdL)\n  2. After washout: 1.94 mmol\u002FL (6.0 mg\u002FdL) ≤ serum phosphate \\\u003C 3.23 mmol\u002FL (10.0 mg\u002FdL)\n\nKey Exclusion Criteria:\n\n* History or plan of kidney transplantation\n* History or plan of parathyroid intervention 6 months before signing the ICF\n* Serum calcium \\\u003C 1.9 mmol\u002FL (7.6 mg\u002FdL) or \\> 2.75 mmol\u002FL (11 mg\u002FdL) at screening\n* Serum intact parathyroid hormone \\> 127 pmol\u002FL (1200 pg\u002FmL) at screening\n* Presence of clinically significant gastrointestinal (GI) disorder\n* History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF\n* Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care\n* Female who are breastfeeding","12 Years",{"count":121,"type":20},264,[123],"PHASE3","The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:\n\n* Does AP301 lower blood phosphate levels?\n* Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?\n* What discomfort or medical problem do the patients have when taking AP301?\n* Does AP301 improve quality of life in Chinese patients?\n\nThe researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.\n\nIn the study, the patients will experience the following stages in a chronicle order:\n\n* Stop all using blood phosphate-lowering drugs,\n* Take AP301 or the comparator three times a day for 8 weeks,\n* Take AP301 three times a day for 24 weeks, and\n* Take AP301 or the comparator three times a day for 3 weeks.\n\nIn the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.\n\nIf the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.",[26,126,127,128],"Chronic Kidney Disease, Receiving Dialysis","ESRD (End-Stage Renal Disease)","Dialysis",[26,130,128,131],"AP301","ESKD","2026-01-28",{"date":134,"type":38},"2026-01-29",{"date":136,"type":38},"2025-06-13",{"date":138,"type":20},"2027-01-10",{"name":140,"class":45},"Alebund Pharmaceuticals",42,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100329735","pragmatic-randomised-trial-of-high-or-standard-phosphate-targets-in-end-stage-kidney-disease-phosphate-100329735","NCT03573089","Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)","An Investigator-initiated, International, Multi-centre, Prospective, Randomized, Open-label, Parallel-group, Superiority, and Pragmatic Large Simple Trial (LST) to Determine Whether the Currently Recommended Strategy of Intensive Reduction of Serum Phosphate Concentration Towards the Normal Level Results in Significant Patient-centred Benefits in End-stage Kidney Disease (ESKD) Patients Receiving Dialysis.","PHOSPHATE","Inclusion Criteria:\n\n1. Age ≥45 years, or Age ≥18 years with diabetes,\n2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,\n3. Currently prescribed at least one phosphate-lowering medication at any dose\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Elective kidney transplantation scheduled,\n2. Concomitant major illness \u002F comorbidity that may result in death in the next 6 months in the view of the treating physician,\n3. Participation in an interventional study that is likely to affect serum phosphate concentration.",{"count":151,"type":20},3600,[153],"NA","During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.",[156,26],"Kidney Failure, Chronic",[158,159,160,161,162,163,26],"Renal dialysis","Randomised controlled trial","Bone markers","Cardiovascular risk factors","Phosphate lowering agent","End stage kidney disease","2025-06-29",{"date":166,"type":38},"2025-07-01",{"date":168,"type":38},"2019-12-10",{"date":170,"type":20},"2028-12-31",{"name":172,"class":109},"The University of Queensland",115,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":179,"conditions":184,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100567126","phase-2-evaluate-the-efficacy-and-safety-of-jmkx003002-in-end-stage-renal-disease-patients-on-hemodialysis-with-hyperphosphatemia-100567126","NCT06664125","Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia","A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia","Inclusion Criteria:\n\n1. Able to understand the procedures of this trial and provide written informed consent voluntarily;\n2. Age ≥ 18 years, male or female;\n3. On a stable hemodialysis regimen at a frequency of two or three times per week for at least 12 weeks prior to the screening visit;\n4. Serum phosphorus within the trial-required range.\n\nExclusion Criteria:\n\n1. Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome;\n2. Pregnant or breastfeeding;\n3. Any history of a parathyroid intervention;\n4. Diarrhea or loose stools occurred within 1 week prior to randomization.",{"count":182,"type":20},50,[23],[26],"2025-01-31",{"date":187,"type":38},"2025-02-03",{"date":189,"type":38},"2024-12-30",{"date":191,"type":20},"2025-09-30",{"name":193,"class":45},"Jemincare",2]