[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"R1 Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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,""]