Phase 3 Study of Roxadustat to Treat Anemia in Non–Dialysis-Dependant CKD

Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients

BACKGROUND Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis. This Phase 2a study tested efficacy (Hb response) and safety of roxadustat in anemic nondialysis-dependent chronic kidney disease (NDD-CKD) subjects. METHODS NDD-CKD subjects with hemoglobin (Hb) ≤11.0 g/dL were sequentially enrolled into four dose cohorts and rando...

A New Approach to the Management of Anemia in CKD Patients: A Review on Roxadustat.

This article informs the reader of the current information available on a novel therapeutic agent and new class of drug for the treatment of anemia. The data show promising results for alternative erythropoietin-stimulating agents and offers a time line of when Phase III data will be available. The information on this new drug and new drug class will change how nephrologists approach treating a...

Chapter 2: Use of iron to treat anemia in CKD

BACKGROUND Correction of iron deficiency with oral or intravenous iron supplementation can reduce the severity of anemia in patients with CKD. Untreated iron deficiency is an important cause of hyporesponsiveness to ESA treatment. It is important to diagnose iron deficiency because treatment can readily correct the associated anemia and investigation for the cause of iron deficiency, which shou...

Chapter 4: Red cell transfusion to treat anemia in CKD

USE OF RED CELL TRANSFUSION IN CHRONIC ANEMIA Repeated transfusions or use of an erythropoiesis-stimulating agent (ESA) are treatment options for chronic anemia in CKD. The choice between these depends on their relative benefits and harms, which vary among patients. For example, patients with a previous stroke have the greatest absolute risk of ESA-related stroke, whereas multiparous women have...

Chapter 3: Use of ESAs and other agents* to treat anemia in CKD