
OR WAIT null SECS
FDA decisions, KDIGO guidelines, and federal nutrition updates redefine kidney care in January 2026
January 2026 updates in nephrology are redefining care for chronic kidney disease (CKD), focal segmental glomerulosclerosis (FSGS), IgA nephropathy (IgAN), and dialysis patients.
The US Food and Drug Administration (FDA) has issued multiple regulatory actions, including priority review and extended timelines, while the 2025–2030 Federal Dietary Guidelines provide new guidance on protein and kidney-friendly nutrition. Meanwhile, the 2026 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Anemia in CKD offers updated recommendations on iron therapy, hemoglobin management, and red blood cell transfusions.
Catch up on the 6 headlines you missed from HCPLive’s editorial team in January 2026.
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.
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.
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).
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.
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.
In a 12-week, 31-center phase 2 clinical trial in 10 countries, apecotrep (BI 764198) reduced proteinuria by 40% in individuals with primary FSGS. Apecotrep, a potential first-in-class, oral, selective TRPC6 inhibitor, is being investigated as a novel, targeted, nonimmunosuppressive therapy in FSGS. The therapy is designed to protect podocytes and decrease the rate of disease progression by reducing proteinuria.