Hypoxia-Inducible Factor Activators in Renal Anemia: Current Clinical Experience.
Neil S Sanghani, Volker H Haase
https://pubmed.ncbi.nlm.nih.gov/31477256/Actively Recruiting
Led by Mansoura University · Updated on 2025-05-11
46
Participants Needed
1
Research Sites
2 weeks
Total Duration
People with severe kidney failure who require regular hemodialysis often face several health challenges such as anemia, bone health problems, and mental health issues like depression and anxiety. This research aims to understand whether Roxadustat, a newer oral medicine for anemia, can also affect bone health and psychological well-being in these patients. The study focuses on assessing bone density, mood symptoms, and nerve and muscle changes in people undergoing hemodialysis. The trial randomly assigns 46 patients on chronic hemodialysis into two groups. One group receives Roxadustat pills three times a week alongside their usual care, while the other group continues with conventional anemia treatment including injectable medications. The treatment period lasts for 6 months, during which Roxadustat dosing may be adjusted based on hemoglobin levels. Participants will have regular evaluations including blood tests, bone density scans using quantitative computed tomography, nerve and muscle ultrasound exams, and questionnaires assessing depression and anxiety. These assessments occur at the start and at intervals during the 6-month study to measure changes in bone mineral density, mood, and neuromuscular structure. Researchers will compare results between the two groups to understand the broader effects of Roxadustat in hemodialysis patients.
CONDITIONS
Roxadustat for Bone and Neuropsychiatric Aspects in Hemodialysis Patients
M
Mostafa I Alaskary, M.Sc
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Mansoura University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either oral Roxadustat three times per week or conventional anemia management according to standard clinical practice. Treatment is adjusted based on hemoglobin levels.
Monthly visits for laboratory tests and clinical assessments; baseline, 3-month, and 6-month visits for additional evaluations
Duration - At treatment end (6 months)
Participants undergo follow-up evaluations including assessments of bone mineral density, peripheral nerve and muscle morphology, handgrip strength, and psychiatric scales to evaluate treatment effects.
Assessments at 6 months including imaging and clinical evaluations
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Neil S Sanghani, Volker H Haase
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https://pubmed.ncbi.nlm.nih.gov/32150252/Qiaoqiao Zhou, Mian Mao, Jing Li...
https://pubmed.ncbi.nlm.nih.gov/37489561/Mansoura University
Lead Sponsor