[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585530":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":35,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":35,"enrollmentInfo":74,"targetDuration":35,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":45,"whyStopped":35,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Roxadustat Group","EXPERIMENTAL","Participants randomized to this arm will receive oral Roxadustat (Evernzo) three times per week according to standard dosing guidelines for managing anemia in hemodialysis patients. Participants will continue standard care for other conditions but will discontinue other erythropoiesis-stimulating agents (ESAs). Dosing may be adjusted based on hemoglobin response as per protocol and product labeling.",[13],"Drug: Roxadustat",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Treatment Group","ACTIVE_COMPARATOR","Participants randomized to this arm will continue receiving their conventional management for renal anemia, typically including erythropoiesis-stimulating agents (ESAs) and\u002For intravenous iron, as determined by standard clinical practice at the study site. Participants will receive standard care for all other conditions.",[19],"Drug: Conventional Anemia Management",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Roxadustat","Intervention Description: Oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Administered orally three times per week. Dosage will be initiated and adjusted according to prescribing guidelines for the treatment of anemia associated with chronic kidney disease in patients on dialysis, based on hemoglobin levels.",[9],[27],"Evernzo",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Conventional Anemia Management","Standard of care treatment for renal anemia, typically involving administration of erythropoiesis-stimulating agents (ESAs, e.g., epoetin, darbepoetin) and\u002For intravenous iron supplementation. Dosing and specific agents used are per standard clinical practice at the study site and adjusted based on hemoglobin levels and iron status according to prevailing guidelines.",[15],[33,34],"Erythropoiesis-Stimulating Agent","Iron Supplementation",null,[37],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Ibrahim M Galalah, MSC","CONTACT","+201027794586","ibrahimgalalah@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Urology and Nephrology Center, Mansoura University","RECRUITING","Al Mansurah","Dakahliya","35111","Egypt","EG",{"type":52,"coordinates":53},"Point",[54,55],31.38069,31.03637,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":40,"phoneExt":35,"email":41},"Ibrahim M Galalah",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Ibrahim Mohammed Galalah","Principal Investigator","100585530","phase-1-roxadustats-effect-on-heart-nutrition-and-inflammation-in-hemodialysis-patients-100585530",false,"NCT06903559","Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients","Effect of Roxadustat on Cardiovascular System and Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome in Hemodialysis Patients: A Randomized Controlled Study","ROXA-HD-MIA","Inclusion Criteria:\n\n* Age of patient is more than 18.\n* Patients who are willing to sign informed consent.\n* Patients with ESKD on chronic hemodialysis for more than 3 months.\n\nExclusion Criteria:\n\n* Current pregnancy or lactation.\n* Patients with pre-existing malignancy.\n* Patients with psychosis or on hypnotics.\n* Refuse to participate in the study.\n* Known history of hematological disorders or other known causes for anemia other than CKD or dialysis.\n* Patients with severe cardiovascular disease","ALL","18 Years",{"count":75,"type":76},46,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","Patients with kidney failure who require hemodialysis often suffer from anemia (low red blood cell count), heart and blood vessel problems, and a condition involving poor nutrition, inflammation, and hardening of the arteries (called MIA syndrome). Standard treatments for anemia often involve injections and iron supplements. This study aims to see if a newer oral medication, Roxadustat, works better than these standard treatments not only for anemia but also for improving cardiovascular health and the MIA syndrome.\n\nParticipants in the study will be randomly assigned (like by chance) to one of two groups. One group will receive Roxadustat, while the other group will continue with their conventional anemia treatment. Researchers will compare the effects on heart function, markers of nutrition and inflammation, and anemia levels in both groups over a 6-month period.",[83,84,85,86],"Kidney Failure, Chronic","Malnutrition-Inflammation Syndrome","Anemia in End Stage Renal Disease","Cardiovascular Diseases (CVD)",[23,88,89,90,91],"Hemodialysis","Renal Anemia","Cardiovascular Diseases","Malnutrition-Inflammation-Atherosclerosis Syndrome","2025-05-08",{"date":94,"type":95},"2025-05-13","ACTUAL",{"date":97,"type":95},"2025-04-15",{"date":99,"type":76},"2025-11-01",{"name":5,"class":6},1]