FDA Requests Clarification of Data to Complete Roxadustat Review
The Agency announced that additional clarification of clinical data was needed prior to completing the review.
Anemias
Anti-Inflammatory Drug May Improve ESA Hyporesponsiveness in HD
In a short-term trial involving hemodialysis patients, ziltivekimab significantly improved erythropoietin resistance index.
IV Iron Products: Adverse Events, Associated Costs Compared
The comparative study aimed to analyze AEs as well as estimate the associated medical costs for 4 IV iron preparations.
Molidustat Noninferior to Darbepoetin in Hemodialysis
The new evidence further supports development of the investigational HIF-PHI, which recently also demonstrated noninferiority to darbepoetin in patients with chronic kidney disease not receiving dialysis.
Iron Deficiency Is Associated With Worse Quality of Life in CKD
Low transferrin saturation was associated with worse physical quality of life in patients with CKD, even in those free of anemia.
Roxadustat Not Linked With Increased Neoplasm Risk
Although hypoxia-inducible factors (HIF) are increased in many forms of cancer, roxadustat, which increases HIF activity, did not show an increased cancer signal in trials.
Postoperative Acute Kidney Injury Found to Predict Anemia
Higher stages of AKI and longer duration of AKI were associated with more severe anemia.
High-Dose vs Low-Dose IV Iron Dosing Regimens Compared
Ferric carboxymaltose can be safely administered at doses of 500 mg in hemodialysis patients, according to a new study.
Risk for Ophthalmic Problems Not Higher With HIF-PHI Use
Investigators analyzed retinal hemorrhages and macular edema events in patients treated with roxadustat or darbepoetin alfa.
Adverse Event Rates Higher in the Early Post-RBC Transfusion Period
Red blood cell transfusions can treat anemia over the short term but may increase the risk for adverse events, particularly those associated with blood volume, according to investigators.
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