RecruitingPhase 1Phase 2NCT06903559

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

Sponsor

Mansoura University

Enrollment

46 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases (CVD)Kidney Failure, Chronic Malnutrition-Inflammation Syndrome Anemia in End Stage Renal Disease

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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.

Exclusion Criteria6

Current pregnancy or lactation.
Patients with pre-existing malignancy.
Patients with psychosis or on hypnotics.
Refuse to participate in the study.
Known history of hematological disorders or other known causes for anemia other than CKD or dialysis.
Patients with severe cardiovascular disease

Interventions

DRUGRoxadustat

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.

DRUGConventional Anemia Management

Standard 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.