Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Roxadustat
DrugOral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Administered orally three times per week. Dosage will be initiated and adjusted according to prescribing guidelines for treating anemia associated with chronic kidney disease in patients on dialysis based on hemoglobin levels.
Conventional Anemia Management
DrugStandard of care treatment for renal anemia, typically involving administration of erythropoiesis-stimulating agents (ESAs, e.g., epoetin, darbepoetin) and/or intravenous iron supplementation. Dosing and specific agents used are per standard clinical practice at the study site and adjusted based on hemoglobin levels and iron status according to prevailing guidelines.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Roxadustat GroupExperimental treatment 1 intervention
Group B: Conventional Treatment GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Lumbar Spine Bone Mineral Density
Change from baseline in cortical and trabecular bone mineral density (BMD) and volume assessed at the lumbar spine using Quantitative Computed Tomography (QCT). Measured typically in mg/cm³.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Change in Peripheral Nerve Morphology via Ultrasound
Change from baseline in cross-sectional area of selected peripheral nerves assessed using Musculoskeletal Ultrasound (MSK-US).
Time frame
Baseline and 6 months2
Change in Muscle Morphology via Ultrasound
Change from baseline in selected muscles echogenicity assessed using Musculoskeletal Ultrasound (MSK-US).
Time frame
Baseline and 6 months3
Change in Handgrip Strength
Change from baseline in muscle function as measured by Handgrip Strength test (e.g., measured in kilograms).
Time frame
Baseline and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov