Actively Recruiting
Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
Led by Mansoura University · Updated on 2025-05-11
46
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
People with severe kidney failure who need regular hemodialysis treatment often experience several health problems. These include anemia (low red blood cell count), issues with their bone health (sometimes called mineral and bone disease), and mental health challenges like depression and anxiety. They may also have problems with their nerves and muscles. Roxadustat is a newer medicine, taken as a pill, used to treat anemia caused by kidney disease. It works differently than the standard injectable medications often used. This study aims to investigate if Roxadustat has effects beyond treating anemia in hemodialysis patients. Specifically, researchers want to see if taking Roxadustat affects patients' bone health (measured by bone density scans and blood tests) and their psychological well-being (looking at symptoms of depression and anxiety using questionnaires). The study will also use ultrasound to look at potential changes in nerves and muscles. The study will enroll 46 patients on hemodialysis. Patients will be randomly assigned (like flipping a coin) into two groups. One group (23 patients) will receive Roxadustat three times a week, while the other group (23 patients) will continue receiving their usual conventional treatment for anemia. All patients will be followed for 6 months. During this time, they will have regular blood tests, bone density scans (using a technique called QCT), nerve and muscle ultrasound examinations, and will complete questionnaires about their mood. Researchers will compare the results between the two groups to understand the effects of Roxadustat on bone, mood, anxiety, and neuromuscular aspects in patients undergoing hemodialysis
CONDITIONS
Official Title
Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Willingness to sign informed consent
- End stage kidney disease patients on chronic hemodialysis for more than 3 months
You will not qualify if you...
- Current pregnancy or breastfeeding
- Pre-existing cancer
- Diagnosis of psychosis
- History of blood disorders or anemia causes other than chronic kidney disease
- Use of medications affecting bone metabolism such as osteo-anabolics or bone resorptives within the last 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahliya, Egypt, 35111
Actively Recruiting
Research Team
M
Mostafa I Alaskary, M.Sc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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