A Phase 3, Open-Label, Uncontrolled Study to Evaluate the Activity, Safety of Roxadustat
Research type
Research Study
Full title
A Phase 3, Open-Label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants with Chronic Kidney Disease (CKD)
IRAS ID
1007547
Contact name
Astellas Head of Regulatory Affairs Clinical Trial Unit
Contact email
Sponsor organisation
Astellas Pharma Global Development Inc.
Eudract number
2022-501980-42
Research summary
Roxadustat is a licensed medicine to treat anaemia in adults with chronic kidney disease (CKD). Anaemia is a low level of red blood cells. Current treatment for anaemia is to have injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help the bone marrow make more red blood cells. These are often given together with iron. This treatment is also available to children and teenagers with CKD. However, there are some safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option for treating anaemia in children and teenagers with CKD. In this study, children and teenagers with CKD will take roxadustat for up to 52 weeks to treat their anaemia.
REC name
Wales REC 3
REC reference
23/WA/0265
Date of REC Opinion
19 Oct 2023
REC opinion
Further Information Favourable Opinion