Tests roxadustat for bone and mood effects in dialysis patients
Compares roxadustat with usual anemia treatment in adults on hemodialysis for kidney failure.
Key facts
- Who runs it
- Mansoura University
- Where
- Al Mansurah, EgyptSee the site
- Trial code
- Registry title
- Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 46 people, planned
- Started
- 15 Apr 2025
- Planned end
- 1 Nov 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Roxadustat
- Conventional Anemia Management
- Record updated
- 11 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with end stage kidney disease who have been on regular hemodialysis for more than 3 months.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- End stage kidney disease on chronic hemodialysis for more than 3 months.
- Earlier treatment
- People who took bone-active medicines such as osteo-anabolics or bone resorptives in the last 6 months cannot join.
Main reasons for not taking part
- Pregnant or breastfeeding
- Existing cancer
- Psychosis
- Blood disorders or other causes of anemia besides chronic kidney disease
- Bone-affecting medicines in the last 6 months
This trial only enrols participants on dialysis. The registry sentence this rests on: Patients with ESKD on chronic hemodialysis for more than 3 months.
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Taking medications that may significantly affect or interact with bone metabolism such as osteo-anabolics or bone resorptives during the last 6 months
- Patients with pre-existing malignancy
- Known history of hematological disorders or other causes of anemia other than CKD
- Current pregnancy or lactation
- patients with psychosis
Where in Egypt
- Urology and Nephrology Center, Mansoura UniversityAl Mansurah, EgyptContact: Mostafa I AlaskaryTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 2 groups in the trial
- Roxadustat GroupTreatment being tested
Participants randomized to this arm will receive oral Roxadustat (Evernzo) three times per week according to standard dosing guidelines for managing anemia in hemodialysis patients. Participants will continue standard care for other conditions but will discontinue other erythropoiesis-stimulating agents (ESAs). Dosing may be adjusted based on hemoglobin response as per protocol and product labeling.
Treatment: Roxadustat
- Conventional Treatment GroupExisting treatment, for comparison
Participants randomized to this arm will continue receiving their conventional management for renal anemia, typically including erythropoiesis-stimulating agents (ESAs) and/or intravenous iron, as determined by standard clinical practice at the study site. Participants will receive standard care for all other conditions.
Treatment: Conventional Anemia Management
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Roxadustat on Bone and Neuropsychiatric Aspects in End Stage Kidney Disease Patients on Hemodialysis
- Plain-language title
- Tests roxadustat for bone and mood effects in dialysis patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 May 2025