Anemia – Allocare

November 9, 2021August 16, 2022

Investigational Oral CKD-Anemia Agent Effective, Safe

“The investigational hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI) daprodustat was safe and as effective as erythropoiesis-stimulating agents (ESAs) for anemia, according to the phase III ASCEND program.

In the first of the two ASCEND trials looking at patients with chronic kidney disease undergoing dialysis, patients treated with oral daprodustat had a mean change in hemoglobin level of 0.28±0.02 g/dL from baseline to weeks 28 through 52, reported Ajay Singh, MBBS, MBA, of Brigham and Women’s Hospital in Boston and chair of the ASCEND program’s Executive Steering Committee, and colleagues.”

Safety Concerns Turn FDA Panel Thumbs Down for Novel CKD-Anemia Drug

An FDA advisory committee almost unanimously agreed that the risks were just too high for the chronic kidney disease (CKD)-related anemia drug roxadustat in any patient population.

In a 13-1 vote Thursday, members of the Cardiovascular and Renal Drugs Advisory Committee felt that although there’s an unmet need for new anemia therapeutics, this particular drug carried too strong of a safety signal for thrombotic risk in a non-dialysis dependent patient population.

Heart, Death Risks Linked With CKD-Related Iron Deficiency

Regardless of anemia, iron deficiency in patients with late-stage chronic kidney disease (CKD) was linked with adverse health outcomes, an observational study found.

In 5,145 patients with stage 3-5 CKD not on dialysis, a transferrin saturation (TSAT) of 15% or less was associated with a higher risk for all-cause mortality before reaching dialysis or kidney transplant, as compared to TSAT levels of 26-35% (HR 1.44, 95% CI 1.03-2.01), according to Roberto Pecoits-Filho, MD, PhD, of the Arbor Research Collaborative for Health in Ann Arbor, Michigan, and colleagues.