Effect of Roxadustat on heart health and nutrition in hemodialysis patients
Effect of Roxadustat on Cardiovascular System and Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome in Hemodialysis Patients: A Randomized Controlled Study
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahliya) |
| Trial ID | NCT06903559 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with end-stage kidney disease on chronic hemodialysis for more than three months.
Not a fit: Patients who are pregnant, have pre-existing malignancies, severe cardiovascular disease, or other hematological disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Al Mansurah, Dakahliya
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.