Follow Us:
Follow Us:
New Federal Dietary Guidelines Impact on Chronic Kidney Disease Management, With Tim Pflederer, MD
Tim Pflederer broke down the 2025-2030 Federal Dietary Guidelines for Americans, released by the US Department of Health and Human Services. He expanded upon the recommended increase in protein, explaining how clinicians can help guide their patients with impaired kidney function, especially those with chronic kidney disease (CKD), to kidney-friendly nutrition.
FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis
On January 13, 2026, the FDA announced its extended review of the supplemental New Drug Application (sNDA) for sparsentan (Filspari) to treat focal segmental glomerulosclerosis (FSGS). After the drug received a Major Amendment, the FDA moved the new PDUFA target action date to April 13, 2026.
FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy
Atacicept, a B-cell modulating therapy, for adults with IgAN received priority review of its Biologics License Application, supported by interim data analysis from ORIGIN 3, which met its primary endpoint of proteinuria reduction at week 36, with a 46% reduction compared to baseline, and a 42% reduction compared to placebo (P < .0001).
KDIGO Releases New Guideline for Anemia in Chronic Kidney Disease
On January 5, 2026, KDIGO Anemia Work Group released the 2026 Clinical Practice Guideline for the Management of Anemia in CKD. Broken down into 4 main chapters, the first addresses the diagnosis and evaluation of anemia and iron deficiency in patients with CKD, including prevalence, pathophysiology, and clinical outcomes. The second focuses on iron therapy for anemia in CKD and prioritizes intravenous iron over oral formulations. The third chapter covers the use of erythropoiesis-stimulating agents and HIF-PHIs to raise hemoglobin, emphasizing shared decision-making and evaluation of alternative causes before treatment initiation. Lastly, the fourth outlines appropriate use of RBC transfusions, highlighting potential risks and recommending symptom-based assessment rather than hemoglobin thresholds alone.
FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD, Dialysis
The FDA accepted Unicycive Therapeutics’ NDA for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with CKD on dialysis on January 29, 2026. The Agency has deemed the OLC resubmission to be a Class II complete response, which has a 6-month review period from the date of resubmission. The PDUFA target action date is June 29, 2026.