Dual-Purpose pill: roxadustat may fight both anemia and muscle wasting in dialysis
NCT ID NCT07162090
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether roxadustat, a drug currently used to treat anemia in kidney disease, can also improve sarcopenia (muscle loss) in patients on hemodialysis. Sixty adults with end-stage kidney disease and anemia will receive either roxadustat or standard erythropoietin. Researchers will measure changes in muscle strength, size, and walking speed over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Roxadustat (a pill that helps the body produce more red blood cells and may affect muscle health)
- What this could lead to
- If it works, roxadustat could offer a way to treat both anemia and muscle loss in dialysis patients with a single pill.
- What could go wrong
- This is a small, early-phase study with only 60 participants, so results may not apply to everyone. Roxadustat is already used for anemia, but its effect on muscle loss is unproven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age: 18 to 80 years old (inclusive), gender unrestricted. * End-stage renal disease and maintenance hemodialysis for at least 16 weeks. * The average Hb level is 7.0\~10.0 g/dL (the last two evaluations). * And have not received or have discontinued ESA/roxadustat treatment. * Vascular access: internal fistula or long-term hemodialysis catheter. * Weight between 45-100 kg. * Sarcopenia Diagnosis (Reference: AWGS 2019 Consensus): * Decreased muscle strength: Male grip strength \< 28 kg, female grip strength \< 18 kg. * Muscle mass decline: Assessed by bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA), it is characterized by appendicular skeletal muscle mass index (ASMI): \< 7.0 kg/m² for men and \< 5.7 kg/m² for women (BIA standard, the device and formula used should be specified). * Sarcopenia can be diagnosed when both "decreased muscle strength" and "reduced muscle mass" are present. If resources permit, "decreased physical function" (such as a 6-meter walking speed \< 1.0 m/s) can be added as an indicator for severity grading. * Voluntary participation in this study. * Must be able to swallow tablets。 Exclusion Criteria: * Non-renal anemia: Anemia caused by other main reasons (such as thalassemia, megaloblastic anemia due to vitamin B12 or folic acid deficiency, active bleeding, hemolytic anemia, hematological malignancies, etc.). * Contraindications and related risks of Roxadustat: * People who are allergic to roxadustat or any of its excipients. * Uncontrolled hypertension (sitting systolic blood pressure remains \> 160 mmHg or diastolic blood pressure \> 100 mmHg after active antihypertensive treatment). * There have been thrombotic events such as acute myocardial infarction, unstable angina pectoris, stroke, deep vein thrombosis or pulmonary embolism within the past six months. * Those with known active malignant tumors or undergoing anti-tumor treatment (except for basal cell carcinoma, etc.) are excluded. * Diseases affecting muscle metabolism and assessment: * Severe thyroid dysfunction (uncontrolled). * Diagnosed with chronic liver cirrhosis, acute exacerbation of chronic obstructive pulmonary disease (COPD), congestive heart failure (NYHA class IV), and other chronic diseases that seriously affect muscle metabolism. * Due to severe limitations in limb movement caused by rheumatoid arthritis, Parkinson's disease, spinal cord injury, etc., it is impossible to complete muscle strength and functional tests. * Long-term and excessive use of glucocorticoids (equivalent to prednisone \> 7.5 mg/day) or other drugs that may affect muscle metabolism (such as androgens). * Other serious systemic diseases: * Severe liver dysfunction (Child-Pugh grade C or ALT/AST \> 3 times the upper limit of normal). * Active, uncontrolled severe infection. * Life expectancy is less than one year. * Special circumstances related to the research: * A kidney transplant is planned within the next six months. * Has participated in any other interventional clinical trials within the past 3 months. * Poor compliance and special populations: * There are mental or cognitive impairments, making it impossible to understand or cooperate with the research. * Pregnant or lactating women, or women of childbearing age who are unwilling to take effective contraceptive measures during the study period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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