Clinical Trial

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

Study acronym: ROXA-BN-HD
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated May 11, 2025 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-05.
Status change: Not Yet Recruiting → Recruiting 2025-05-07
Trial Details
NCT Number NCT06917950
Lead Sponsor Mansoura University
Conditions Kidney Failure,Chronic, Anemia in End Stage Renal Disease, Depression Anxiety Disorder
Enrollment 46 participants
Start Date 2025-04-15
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-11