In short
Clinical trials are studying Roxadustat in different patient groups, including children with chronic kidney disease and people with cardiovascular and metabolic risk factors. These studies look at safety, activity, and how the treatment affects blood counts, cholesterol, and other body functions.
Key points
- Clinical trials of Roxadustat are studying two different patient groups. One Phase 3 trial looks at children and adolescents with chronic kidney disease and anemia, focusing on hemoglobin change over time. Another Phase 3 trial studies people with cardiovascular disease risk factors and metabolic syndrome, looking at cholesterol, glucose and lipid metabolism, and cardiovascular function. Both trials are authorised. The pediatric anemia study is open-label and uncontrolled, while the cardiometabolism study includes placebo comparison. Together, these trials focus on safety, activity, and treatment effects in specific populations.
Clinical trials overview
Two authorised Phase 3 studies are listed for Roxadustat, and both are interventional trials, which means a treatment is given and studied in people.
These trials focus on different patient groups: one in children and adolescents with anemia linked to chronic kidney disease, and one in people with risk factors for cardiovascular disease and metabolic syndrome.
Pediatric anemia in chronic kidney disease
The pediatric study is an open-label, uncontrolled Phase 3 trial that evaluates the activity, safety, pharmacokinetics, and pharmacodynamics of Roxadustat in children and adolescents with anemia associated with chronic kidney disease.
Open-label means everyone knows which treatment is being used, and uncontrolled means there is no separate comparison group in the study design.
The study plans to enroll 104 participants and has a 24-week treatment period with 4 weeks of fixed dose treatment followed by 20 weeks of dose titration, which means the dose can be adjusted over time.
Cardiometabolism and cardiovascular risk
The other authorised Phase 3 trial studies the effect of Roxadustat on cardiometabolism, with a focus on glucose and lipid metabolism and cardiovascular function in people with risk factors for cardiovascular disease and metabolic syndrome.
This study includes a placebo, which is an inactive treatment used for comparison, and it plans to enroll 24 participants.
The trial title and summary show that researchers want to understand how Roxadustat affects body processes linked to sugar, fats, and heart health.
Study design, phase, and who can participate
Both studies are interventional, meaning they are designed to test the effect of Roxadustat in real participants rather than only observing usual care.
The pediatric study includes adolescents and children with chronic kidney disease and anemia, while the cardiometabolism study includes participants with cardiovascular and metabolic risk factors.
Because both are Phase 3 studies, they are focused on testing the treatment in a more advanced stage of clinical research.
Main endpoints being measured
In the pediatric study, the main endpoint is the change in hemoglobin from the start of treatment to the average hemoglobin level during treatment weeks 20 to 24.
In the cardiometabolism study, the main endpoint is plasma total cholesterol levels.
The pediatric study also evaluates safety, pharmacokinetics, and pharmacodynamics, while the cardiometabolism study looks at glucose and lipid metabolism and cardiovascular function as part of its brief summary.