[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623135":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":47,"collaborators":24,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":24,"maxAge":24,"enrollmentInfo":57,"targetDuration":24,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":70,"whyStopped":24,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Haukeland University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amino Acid Supplementation","EXPERIMENTAL","* Product: Synthamin 9® (Baxter), a sterile, pyrogen-free solution of amino acids for injection (5.5%).\n* Dose: 250 ml per administration, providing approximately 13.7 g of free amino acids.\n* Administration: Intravenously during the first hour of hemodialysis.\n* Frequency: Twice weekly (preferably on the two longest HD sessions) for 12 months.",[13],"Dietary Supplement: Amino Acid Supplementation",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","* A sterile, pyrogen-free saline solution\n* Administration: Intravenously during the first hour of hemodialysis.\n* Frequency: Twice weekly (preferably on the two longest HD sessions) for 12 months.",[19],"Other: Sterile Saline Arm",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Sterile Saline Arm","Product: Isotonic saline solution (0.9% NaCl), 250 ml.\n\n• Administration and frequency: Identical to the intervention arm.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Piotr M Mydel, Md Phd","CONTACT","0047 466 10 782","piotr.mateusz.mydel@helse-bergen.no",[36],{"facility":37,"status":24,"city":38,"state":24,"zip":24,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":24},"Haukeland Central Hospital","Bergen","Norway","NO",{"type":42,"coordinates":43},"Point",[44,45],5.32415,60.39299,{"lat":45,"lon":44},{"type":48,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100623135","the-intravenous-amino-acid-therapy-for-vascular-rigidity-in-end-stage-renal-disease-100623135",false,"NCT07392697","The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease","NASCAR","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of end-stage renal disease (ESRD) and undergoing maintenance hemodialysis (HD) or online hemodiafiltration (HDF).\n* On a stable dialysis regimen for a minimum of 90 consecutive days prior to enrollment.\n* Serum albumin level ≥30 g\u002FL.\n* Documented dialysis adequacy: single-pool Kt\u002FV (spKt\u002FV) \\> 1.2.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Administration of parenteral amino acids or intravenous nutrition within the past 90 days.\n* Severe hypertension (e.g., SBP \\>180 mmHg despite antihypertensive therapy).\n* Advanced liver disease classified as Child-Pugh class C.\n* Diagnosis of active malignancy or cancer treatment within the last 5 years.\n* Current participation in another interventional study or within the past 30 days.\n* Pregnant or breastfeeding women.\n* Psychiatric or cognitive impairment that interferes with informed consent or study compliance.\n* Life expectancy \\\u003C12 months due to unrelated comorbidities.","ALL",{"count":58,"type":59},120,"ESTIMATED","INTERVENTIONAL",[62],"NA","The goal of this study is to learn if giving amino acids through the dialysis machine can help protect the blood vessels and heart in people with kidney failure. Patients on dialysis often have problems with stiff blood vessels, which increases their risk of heart attacks, strokes, and other cardiovascular diseases. A chemical change called carbamylation is thought to make blood vessels age and stiffen faster. Amino acids may block this process and improve blood vessel health.\n\nThe main questions are:\n\n* Does amino acid treatment reduce the risk of death in dialysis patients?\n* Does it improve the health of the heart and blood vessels?\n* What side effects or medical problems happen when patients receive amino acids during dialysis?\n\nIn this study:\n\n* Participants will be randomly assigned to receive either amino acids (Synthamin 9®) or a placebo (saline).\n* The infusion (250 ml) will be given twice a week during dialysis sessions for 12 months.\n* After 12 months of treatment, patients will be followed for another 6 months.\n\nDuring the study, patients will:\n\n* Have regular blood tests to measure markers of blood vessel health, inflammation, and protein carbamylation.\n* Undergo heart and vessel tests, including echocardiography, CT scans, and pulse wave velocity measurements.\n* Complete quality-of-life questionnaires about symptoms and daily living.\n\nBy comparing the amino acid group with the placebo group, researchers will see whether amino acid therapy can make dialysis patients live longer and have healthier hearts and blood vessels.",[65,66],"Chronic Kidney Disease Requiring Chronic Dialysis","Cardiovascular Calcification",[68,69],"carbamylation","chronic kidney disease","NOT_YET_RECRUITING","2026-01-29",{"date":73,"type":74},"2026-02-06","ACTUAL",{"date":76,"type":59},"2026-02-01",{"date":78,"type":59},"2028-11-01",{"name":5,"class":6},1]