[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605279":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":34,"responsibleParty":41,"collaborators":34,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":34,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":72,"whyStopped":34,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":34},{"fullName":5,"class":6},"Shaikh Zayed Hospital, Lahore","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Levocarnitine + Usual ESA Care","EXPERIMENTAL","Adults on maintenance hemodialysis with renal anemia receive levocarnitine 1,000 mg IV immediately after each dialysis session, three times per week for 6 months, in addition to standard anemia management with erythropoiesis-stimulating agents (ESA) per unit protocol. Monthly assessments of hemoglobin, hematocrit, ESA dose, and erythropoietin responsiveness index (ERI).",[13,14],"Drug: Levocarnitine Injection","Other: Usual ESA-Based Anemia Care",{"label":16,"type":17,"description":18,"interventionNames":19},"Usual ESA Care (No Levocarnitine)","ACTIVE_COMPARATOR","Standard anemia management with ESA per unit protocol without levocarnitine. Monthly assessments of hemoglobin, hematocrit, ESA dose, and ERI over 6 months.",[14],[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Levocarnitine Injection","1,000 mg levocarnitine IV (slow IV push or infusion per unit policy) post-hemodialysis, three times weekly for 6 months (\\~72 doses). Administered in the dialysis unit in addition to usual ESA-based anemia care.",[9],[27,28,29],"L-carnitine","Levocarnitine","Carnitine",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Usual ESA-Based Anemia Care","Standard-of-care anemia management using recombinant human erythropoietin (ESA) per unit protocol. Typical initial dosing: 50-100 U\u002Fkg\u002Fweek if Hb \\\u003C10 g\u002FdL (in 2-3 doses\u002Fweek); 50 U\u002Fkg\u002Fweek if Hb 10-11 g\u002FdL; 25-50 U\u002Fkg\u002Fweek as maintenance if Hb 11-12 g\u002FdL. ESA dose adjusted monthly using ERI and Hb\u002FHct targets (generally Hb 10-12 g\u002FdL).",[9,16],null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Hanzla Doctor, M.Phil Pharmacy","CONTACT","00923131614162","hanzlaarshadbutt@gmail.com",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Hanzla Arshad","Doctor","100605279","phase-4-levocarnitine-for-reducing-esa-requirements-in-hemodialysis-patients-with-renal-anemia-100605279",false,"NCT07160452","Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia","Effect of Levocarnitine Injections on Reducing Erythropoietin-Stimulating Agent Requirements in Hemodialysis Patients With Renal Anemia","L-CAR-ESA","Inclusion Criteria:\n\n1. Both male and female patients\n2. Patients aged 20-60 years.\n3. Patients undergoing maintenance hemodialysis three times a week for at least six months\n4. Patients having renal anemia\n\nExclusion Criteria:\n\n1. Patients currently using any carnitine preparation as a supplement (to avoid confounding effects from additional carnitine intake).\n2. Patients on immunosuppressive drugs, steroids, or antibiotics (to avoid the influence of these medications on anemia and carnitine metabolism).\n3. Patients who have previously received levocarnitine in either oral or injected form (to eliminate any prior influence of levocarnitine on study outcomes).\n4. Patients with a history of blood transfusion within the past 6 months (to exclude the immediate impact of transfusions on hemoglobin levels and anemia management).\n5. Patients with acute inflammation (to prevent interference with study parameters as inflammation can affect anemia status).\n6. Patients with communication difficulties due to dementia or other factors (to ensure accurate symptom reporting and study adherence).","ALL","20 Years","60 Years",{"count":57,"type":58},94,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs). Some patients respond poorly and require high ESA doses, which increases treatment burden, cost, and potential side effects. Carnitine deficiency is frequent in hemodialysis because carnitine is lost during dialysis and its synthesis is reduced. Levocarnitine may improve red blood cell function and reduce the dose of ESA needed to maintain hemoglobin.\n\nThis single-center, randomized controlled trial will test whether adding intravenous levocarnitine to standard care reduces ESA requirements in adults on maintenance hemodialysis who have renal anemia. Ninety-four participants (age 20-60 years) on thrice-weekly hemodialysis for ≥6 months and with hemoglobin \\\u003C10 g\u002FdL will be randomly assigned (1:1) to:\n\nIntervention: Levocarnitine 1,000 mg IV three times per week, administered after each dialysis session, plus usual anemia care including ESA per unit protocol.\n\nControl: Usual anemia care including ESA per unit protocol without levocarnitine.\n\nParticipants will be followed for 6 months. Hemoglobin, hematocrit, ESA dose, and the erythropoietin responsiveness index (ERI = monthly ESA dose ÷ \\[dry weight × average hemoglobin\\]) will be recorded monthly.\n\nThe primary outcome is the ESA dose (units\u002Fweek) at month 6. Secondary outcomes include ERI and monthly changes in hemoglobin and hematocrit, along with routine safety monitoring. If levocarnitine lowers ESA needs, the findings may offer a cost-effective strategy to optimize anemia management in hemodialysis patients.",[64,65,66,67],"Anemia","Kidney Failure","End-Stage Renal Disease","Renal Dialysis",[28,27,69,70,71],"Erythropoiesis-Stimulating Agents","Erythropoietin Responsiveness Index","Hematocrit","NOT_YET_RECRUITING","2025-09-06",{"date":75,"type":76},"2025-09-12","ACTUAL",{"date":78,"type":58},"2025-09-15",{"date":80,"type":58},"2026-03-15",{"name":5,"class":6}]