Effect of Roxadustat on Cardiovascular System and Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome in Hemodialysis Patients: A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Urology and Nephrology Center, Mansoura University
RECRUITING
Al Mansurah
Contact Information
Primary
Ibrahim M Galalah, MSC
ibrahimgalalah@gmail.com
+201027794586
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 46
Treatments
Experimental: Roxadustat Group
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.
Active_comparator: Conventional Treatment Group
Participants randomized to this arm will continue receiving their conventional management for renal anemia, typically including erythropoiesis-stimulating agents (ESAs) and/or intravenous iron, as determined by standard clinical practice at the study site. Participants will receive standard care for all other conditions.
Related Therapeutic Areas
Sponsors
Leads: Mansoura University

This content was sourced from clinicaltrials.gov