Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
Launched by MANSOURA UNIVERSITY · Apr 5, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Roxadustat, which is a pill designed to treat anemia (low red blood cell count) in patients with severe kidney failure who require hemodialysis. Researchers are interested in finding out whether Roxadustat can also help with other health issues that these patients often face, such as bone health problems and mental health conditions like depression and anxiety. The study will include 46 patients who are on hemodialysis, and they will be divided into two groups: one group will receive Roxadustat three times a week, while the other group will continue with their usual treatment for anemia.
To be eligible for the study, participants must be over 18 years old, willing to sign consent, and have been on hemodialysis for more than three months. The trial will last for six months, during which participants will undergo regular blood tests, bone scans to check bone density, ultrasounds to assess nerve and muscle health, and complete questionnaires about their mood. This research aims to compare the effects of Roxadustat with standard treatment and gain insights into how it may benefit bone health and mental well-being in patients undergoing hemodialysis.
Gender
ALL
Eligibility 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.
About Mansoura University
Mansoura University is a prestigious academic institution located in Egypt, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, it leverages its extensive resources and expertise in various fields of healthcare to facilitate innovative research initiatives aimed at improving patient outcomes. The university collaborates with a network of healthcare professionals and researchers to conduct high-quality clinical trials, focusing on addressing critical health challenges through rigorous scientific methodologies. Its dedication to ethical research practices and adherence to regulatory standards underscores its role as a leader in the medical research community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mansoura, Dakahliya, Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported