Roxadustat for treating anemia and improving bone and mental health in hemodialysis patients
Effect of Roxadustat on Bone and Neuropsychiatric Aspects in End Stage Kidney Disease Patients on Hemodialysis
This study is testing if the medication Roxadustat can help improve anemia, bone health, and mental well-being in patients on hemodialysis for kidney disease.
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 | NCT06917950 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Roxadustat, an oral medication, on anemia and its potential benefits for bone health and mental well-being in patients undergoing hemodialysis for end-stage kidney disease. The study aims to assess changes in bone mineral density, psychological symptoms of depression and anxiety, and nerve and muscle function through various tests and questionnaires. A total of 46 patients will be enrolled to evaluate the broader impacts of Roxadustat beyond its primary use for anemia treatment.
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 malignancies, or have other specific hematological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves not only anemia but also bone health and mental health for hemodialysis patients.
How similar studies have performed: While Roxadustat has shown promise in treating anemia, its effects on bone and mental health in hemodialysis patients are less explored, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The age of the 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. * Known history of hematological disorders or other causes of anemia other than CKD. * Taking medications that may significantly affect or interact with bone metabolism such as osteo-anabolics or bone resorptives during the last 6 months.
Where this trial is running
Al Mansurah, Dakahliya
- Urology and Nephrology Center, Mansoura University — Al Mansurah, Dakahliya, Egypt (Recruiting)
Study contacts
- Study coordinator: Mostafa I Alaskary, M.Sc
- Email: drmostafa2110@gmail.com
- Phone: +201017178892
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.