ClinicaliQ Trial Snapshot
- A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease — Recruiting • Phase III • Cardiology / Cardiovascular • NCT05970172.
- What is being tested: Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor already approved for treating anaemia in adult CKD patients, is being investigated for safety and efficacy in children and adolescents with CKD as an alternative to injectable erythropoietin-stimulating agents.
- Patient eligibility overview: The trial recruits paediatric patients (children and teenagers) with chronic kidney disease who have anaemia, providing a younger population cohort that has been under-represented in roxadustat clinical evidence to date.
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What This Trial Is Studying
Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia 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…
Eligibility Snapshot
- : * Participant has a diagnosis of anemia in CKD Kidney Disease Outcomes Quality Initiative stages 3 or 4 or 5. This can include participants not on dialysis or dialysis dependent (DD) participants (including hemodialysis, peritoneal dialysis and hemodiafiltration participants). * Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of < 60 mL/min per 1.73 m^2. * ESA-treated participants should have a screening Hb level, assessed via HemoCue, between 10.0 and 12.0 g/dL; ESA-naïve participants can have a Hb level ≤ 11 g/dL. * Participant has a ferritin level > 100 ng/mL or a transferrin saturation (TSAT) value > 20%. * Participant has an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) and total bilirubin (TBL) ≤ 1.5 x ULN at enrollment visit. * Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as: * ESA-treated: Participant is taking a stable dose of an ESA for at least 4 weeks prior to screening. * ESA-naïve: Participant has no prior ESA exposure OR participant's total prior ESA exposure ≤ 3 weeks within the preceding 4 weeks from screening OR participant was previously treated…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.