A phase 3b, multicenter, open-label, single-arm study of roxadustat (ASPEN): Operational learnings within United States dialysis organizations.

Publication date: Jun 28, 2023

Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in several regions for the treatment of anemia of chronic kidney disease (CKD). ASPEN evaluated the efficacy, safety, and feasibility of roxadustat in patients with anemia of CKD in US dialysis organizations. This open-label, single-arm study (NCT04484857) comprised a 6-week screening period, followed by 24 weeks of treatment (with optional extension ≤1 year) and a 4-week follow-up. Patients aged ≥18 years, receiving chronic dialysis, with hemoglobin (Hb) 9. 0-12. 0 g/dL if converting from erythropoiesis-stimulating agents (ESAs), or

Concepts Keywords
Aspen anemia
Dialysis drugs and dialysis
Nct04484857 outcomes research


Type Source Name
drug DRUGBANK Roxadustat
disease MESH anemia
disease MESH chronic kidney disease

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