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Roxadustat

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.

Table of Contents

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.[1][2]

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.[1][2]

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.[2]

Open-label means everyone knows which treatment is being used, and uncontrolled means there is no separate comparison group in the study design.[2]

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.[2]

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.[1]

This study includes a placebo, which is an inactive treatment used for comparison, and it plans to enroll 24 participants.[1]

The trial title and summary show that researchers want to understand how Roxadustat affects body processes linked to sugar, fats, and heart health.[1]

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.[1][2]

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.[1][2]

Because both are Phase 3 studies, they are focused on testing the treatment in a more advanced stage of clinical research.[1][2]

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.[2]

In the cardiometabolism study, the main endpoint is plasma total cholesterol levels.[1]

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.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2023-508183-29-00Phase 3Risk factors of cardiovascular disease, metabolic syndromeAuthorised24
2022-501980-42-00Phase 3Anemia associated with Chronic Kidney DiseaseAuthorised104

FAQ

  • What are the Roxadustat clinical trials studying? The trials are studying Roxadustat in two main areas: anemia in children and adolescents with chronic kidney disease, and cardiometabolic risk factors such as cholesterol and cardiovascular function.
  • Who can take part in these trials? One trial includes pediatric participants with chronic kidney disease and anemia. Another trial includes people with risk factors for cardiovascular disease and metabolic syndrome.
  • What phases are the Roxadustat trials? Both trials listed are Phase 3 studies. Phase 3 trials usually compare or assess treatment in a larger group of participants.
  • What results are the researchers measuring? One key result is change in hemoglobin, which is the protein in red blood cells that carries oxygen. Another study measures plasma total cholesterol levels and looks at glucose and lipid metabolism and cardiovascular function.
  • Are the Roxadustat trials open to volunteers now? Both trials in the data are authorised. That means they have been approved to start or continue.

Ongoing Clinical Trials on Roxadustat

  • Study on Roxadustat for Treating Anemia in Children with Chronic Kidney Disease

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Bulgaria Croatia Czechia Denmark Finland +14

  • Study on the Effects of Roxadustat and Placebo on Cardiovascular Risk Factors and Metabolic Syndrome in Patients

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Finland

Glossary

  • Anemia: A condition where the body does not have enough healthy red blood cells or hemoglobin, which can cause tiredness and weakness.
  • Chronic kidney disease: Long-term kidney damage that can affect how the kidneys work over time.
  • Pediatric participants: Children and adolescents who take part in a clinical study.
  • Phase 3: A later stage of clinical research that studies a treatment in a larger group of people.
  • Open-label: A study design where participants and researchers know which treatment is being given.
  • Uncontrolled study: A study without a comparison group, such as placebo or another treatment.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Pharmacodynamics: How a treatment affects the body.
  • Hemoglobin: A protein in red blood cells that carries oxygen through the body.
  • Plasma total cholesterol: The total amount of cholesterol measured in the liquid part of the blood.
  • Metabolic syndrome: A group of health problems that raise the risk of heart disease and diabetes.
  • Cardiovascular function: How well the heart and blood vessels are working.

References

  1. https://clinicaltrials.gov/study/2023-508183-29-00
  2. https://clinicaltrials.gov/study/2022-501980-42-00