Effect of Roxadustat on heart health and nutrition in hemodialysis patients
Official title: Effect of Roxadustat on Cardiovascular System and Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome in Hemodialysis Patients: A Randomized Controlled Study
Run by Mansoura University · NCT06903559 · Data updated 2026-11-12
This study is testing if the medication Roxadustat can improve heart health and nutrition in people with kidney disease who are on hemodialysis, compared to standard anemia treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahliya) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | October 15, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT06903559 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with end-stage kidney disease on chronic hemodialysis for more than three months.
✕Probably not a fit
Patients who are pregnant, have pre-existing malignancies, severe cardiovascular disease, or other hematological disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of Roxadustat, an oral medication, on anemia, cardiovascular health, and Malnutrition-Inflammation-Atherosclerosis (MIA) syndrome in patients with end-stage kidney disease undergoing hemodialysis. Participants will be randomly assigned to receive either Roxadustat or conventional anemia treatments, with their heart function, nutritional markers, inflammation levels, and anemia status monitored over a six-month period. The study aims to determine if Roxadustat provides additional benefits beyond correcting hemoglobin levels.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for anemia and cardiovascular health in hemodialysis patients.
How similar studies have gone: While Roxadustat has shown efficacy in managing anemia, its effects on cardiovascular health and MIA syndrome in this specific population are still being explored, making this study a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahliya, Egypt Recruiting
Study contacts
- Study coordinator: Ibrahim M Galalah, MSC
- Email: ibrahimgalalah@gmail.com
- Phone: +201027794586
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.