NCT06917950 Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
| NCT ID | NCT06917950 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Mansoura University |
| Condition | Kidney Failure,Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2025-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2025-04-15 with a primary completion date of 2025-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06917950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Failure,Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06917950 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06917950 currently recruiting?
Yes, NCT06917950 is actively recruiting participants. Contact the research team at drmostafa2110@gmail.com for enrollment information.
Where is the NCT06917950 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT06917950 clinical trial?
NCT06917950 is sponsored by Mansoura University. The trial plans to enroll 46 participants.
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