RecruitingPhase 1Phase 2NCT06917950

Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients

Effect of Roxadustat on Bone and Neuropsychiatric Aspects in End Stage Kidney Disease Patients on Hemodialysis


Sponsor

Mansoura University

Enrollment

46 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether roxadustat — a drug used to treat anemia in kidney disease — can also help improve bone health and mood/mental health in patients who are on long-term hemodialysis (regular dialysis for kidney failure). **You may be eligible if...** - You are over 18 years old - You have end-stage kidney disease and have been on regular hemodialysis for more than 3 months - You are willing to sign informed consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a pre-existing cancer - You have a psychotic disorder - You have anemia from causes other than kidney disease (such as a blood disorder) - You have taken bone-affecting medications (like bone-building or bone-resorption drugs) in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRoxadustat

Oral 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.

DRUGConventional Anemia Management

Standard 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.


Locations(1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahliya, Egypt

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NCT06917950


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