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.
Participants 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.
Age of patient is more than 18.
Patients who are willing to sign informed consent.
Patients with ESKD on chronic hemodialysis for more than 3 months.
Current pregnancy or lactation.
Patients with pre-existing malignancy.
Patients with psychosis or on hypnotics.
Refuse to participate in the study.
Parallel
Roxadustat
DrugIntervention 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.
Conventional Anemia Management
DrugStandard of care treatment for renal anemia, typically involving administration of erythropoiesis-stimulating agents (ESAs, e.g., epoetin, darbepoetin) and/or 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.
Change from Baseline in Left Ventricular Ejection Fraction (LVEF) at 6 Months
Assesses the change in the percentage of blood leaving the left ventricle with each contraction, measured by transthoracic echocardiography at the beginning of the study and after 6 months of treatment. An increase indicates improvement in systolic function.
Change from Baseline in Carotid Intima-Media Thickness (CIMT) at 6 Months
Assesses the change in the thickness of the inner layers of the carotid artery wall, a marker of atherosclerosis. Measured by Doppler ultrasound of the carotid artery at the beginning of the study and after 6 months of treatment. A decrease or smaller increase indicates less progression of atherosclerosis.
Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) Level at 6 Months
Assesses the change in a marker of systemic inflammation. Measured via laboratory blood test at the beginning of the study and after 6 months of treatment. A decrease indicates reduced inflammation.
Change from Baseline in Normalized Protein Catabolic Rate (nPCR) at 6 Months
Assesses the change in protein catabolism, reflecting nutritional status and protein intake adequacy in dialysis patients. Calculated based on urea kinetics (typically from pre- and post-dialysis BUN and dialysis parameters) at the beginning of the study and after 6 months. An increase may indicate improved nutritional status (within appropriate ranges).
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