[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Iperboreal Pharma Srl\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"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},"100362076","phase-3-efficacy-and-safety-of-xylocore-peritoneal-dialysis-solution-100362076",false,"NCT03994471","Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.","A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis","ELIXIR","INCLUSION CRITERIA:\n\n1. Age ≥18 years\n2. Diagnosed with ESRD and treated with CAPD in the last 3 months\n3. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events\n4. Have not experienced peritonitis episodes in the last 3 months\n5. In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month\n6. In treatment with 1, 2 or 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose)\n7. Kt\u002FV urea measurement \\> 1.7 per week at Baseline Visit\n8. Followed\u002Ftreated by the participating clinical Center\u002FInvestigator in the last three months\n9. Understanding the nature of the study and providing their informed consent to participation.\n\nEXCLUSION CRITERIA:\n\n1. History of drug or alcohol abuse in the six months prior to entering the protocol\n2. In treatment with androgens\n3. Clinically significant abnormal liver function test (ɣ-GT \\> 4 times the upper normal limit)\n4. Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)\n5. Expected patient's survival shorter than the trial duration\n6. History of L-Carnitine therapy or use in the month prior to entering the protocol\n7. Have used any investigational drug in the 3 months prior to entering the protocol\n8. Female patients who are pregnant or breast-feeding.\n9. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception\n10. Patients affected by Primary Hyperoxaluria as per known medical therapy\n11. Patients with serum levels of uric acid \\> 7.2 mg\u002Fdl (male and postmenopausal women) or \\> 6.0 mg\u002Fdl (premenopausal women)\n12. Patients with a major cardiovascular event in the last 3 months\n13. Patients with advanced cardiac failure (NYHA 4)\n14. Hypersensitivity to any of the constituents of the study IMPs.\n15. Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.\n16. Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.\n17. History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant AE or interfere with study assessments during the course of the trial as determined by the clinical judgment of the investigator.","ALL","18 Years",{"count":20,"type":21},170,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.",[27],"End Stage Renal Disease",[29,30],"peritoneal dialysis","ESRD","RECRUITING","2026-03-23",{"date":34,"type":35},"2026-03-24","ACTUAL",{"date":37,"type":35},"2022-12-14",{"date":39,"type":21},"2027-04-28",{"name":41,"class":42},"Iperboreal Pharma Srl","INDUSTRY",41,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100362106","phase-1-peritoneal-ultrafiltration-in-cardio-renal-syndrome-100362106","NCT03994874","Peritoneal Ultrafiltration in Cardio Renal Syndrome.","Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation.","PURE","Inclusion Criteria:\n\n* Age ≥18 yrs\n* Left ventricular ejection fraction ≤60%\n* NYHA Classification of III-IV despite guidelines directed medical therapy\n* Right ventricular failure due to after load mismatch, addressed by the presence of tricuspid calve regurgitation (≥ moderate) and by the disproportioned increase of the right atrial pressure (RAP) versus the capillary wedge pressure (CWP) with a ratio ≥0.65, detected with right heart catheterization performed after stable medical therapy according to international guidelines and comprehensive of loop diuretic (equivalent to furosemide oral dose till 2.0 mg\u002Fkg\u002Fday), coupled with urinary sodium excretion ≤ mEq\u002FL, confirmatory of loop diuretic resistance.\n* Cava vein enlargement (inner diameter, detected with focused echocardiography, between 1,5 and 2,5 cm, with respiratory collapse \\\u003C50% or absent due to intravascular fluid overload)\n* Decreased kidney function addressed by the measurement of glomerular filtration rate (GFR) urea clearance + creatinine clearance\u002F2 (\\>15 ml\u002Fmin\u002F1,73 m2)\n* NT pro-BNP plasma concentration \\> 1000 pg\u002Fml or BNP plasma concentration \\> 250 pg\u002Fml\n* at least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics (or diuretic combinations) in the 6 months befor the study enrollment\n* An appropriate PUF technique candidate.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Recipients of heart transplantation\n* Presence of a mechanical circulatory support device;\n* Hypertrophic obstructive cardiomyopathy;\n* Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg\n* Severe valvular stenosis;\n* Restrictive cardiomyopathy;\n* Acute coronary syndrome ≤ 6 months before;\n* Active myocarditis\n* Cardiosurgical or Endo-radiological heart procedures ≤ 6 months before\n* Cardiac resynchronization therapy (CRT) implantation or upgrading of pacemaker (PM) or implantable cardioverter defibrillator (ICD) to CRT ≤ 6 months before;\n* Patient with end-stage renal disease, GFR urea clearance + creatinine clearance\u002F2 (\\\u003C15 ml\u002Fmin\u002F1,73 m2 GFR)\n* Any major organ transplant (liver, lung, kidney)\n* Lung embolism ≤ 6 months before;\n* Fibrotic lung disease;\n* Liver Cirrhosis;\n* Absolute contraindication to peritoneal catheter implantation;\n* Logistical and or organizational contra-indication to treatment\n* Active malignancy;\n* Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical trial and for three months later\n* Female patients of childbearing age who do not use adequate contracteption.\n* Unwilling and unable to give informed consent;\n* Enrolment in another clinical trial involving medical or device based interventions.\n* Hypersensibility to IMP components.\n* Evidence of any condition that, according to the investigators' judgment, could expose the subject to undue risk and\u002For prevent the subject from participating in the study procedures and\u002For potentially afftecting the study quality data.",{"count":53,"type":21},84,[55,56],"PHASE1","PHASE2","Randomized, controlled, unblinded, adaptive design clinical trial to evaluate the safety and efficacy of PolyCore (Polydextrin, L-Carnitine, D-xylitol) peritoneal ultrafiltration (PUF) in patients with heart failure and reduced ejection fraction (HFrEF).",[59],"Congestive Heart Failure","2025-05-13",{"date":62,"type":35},"2025-05-16",{"date":64,"type":35},"2025-04-16",{"date":66,"type":21},"2027-06",{"name":41,"class":42},3,""]