[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582051":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Mario Negri Institute for Pharmacological Research","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patiromer","EXPERIMENTAL","Participants will be stratified according to the number of weekly dialysis sessions (2 vs 3) and within each stratum, and will be randomized on 1:1 basis to 3-month treatment with patiromer.",[13],"Drug: Patiromer 8400 MG [Veltassa]",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will be stratified according to the number of weekly dialysis sessions (2 vs 3) and within each stratum, and will be randomized on 1:1 basis to 3-month treatment with the placebo.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Patiromer 8400 MG [Veltassa]","Randomized patients will receive one 8.4 g packet of patiromer per day or one identical packet containing a placebo. To minimize the possibility of interference with gastrointestinal absorption of other orally administered medications, administration of patiromer will be separated by at least 3 hours from other oral medicinal products. Throughout the whole study period, the study drug will be administered every day in the morning.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Randomized patients will receive one packet of placebo identical to that of patiromer. Following the same treatment sequence of patiromer, administration of the placebo will be separated by at least 3 hours from any other oral medicinal products. As for patiromer, the placebo will be administered every day in the morning.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Piero L Ruggenenti, M.D.","CONTACT","+390352673814","pruggenenti@asst-pg23.it",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Nephrology Unit, ASST Papa Giovanni XXIII","RECRUITING","Bergamo","BG","24127","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],9.66721,45.69601,{"lat":49,"lon":48},[52,53,56],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"name":54,"role":33,"phone":26,"phoneExt":26,"email":55},"Carmela G Condemi, M.D.","ccondemi@asst-pg23.it",{"name":54,"role":57,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100582051","phase-3-patiromer-and-diethrqol-in-chronic-dialysis-100582051",false,"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","ALL","18 Years",{"count":71,"type":72},40,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","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.",[78,79,80],"Hyperkalaemia","Chronic Kidney Disease Stage 3 and 4","Dietary Intervention","2025-08-27",{"date":83,"type":84},"2025-09-04","ACTUAL",{"date":86,"type":84},"2025-07-08",{"date":88,"type":72},"2026-07",{"name":5,"class":6},1]