Nephrology news in October 2026 included an accelerated approval from the US Food and Drug Administration (FDA) in IgA nephropathy (IgAN), along with phase 3 data for 4 additional IgAN therapies presented at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver.
On October 21, 2026, the FDA granted accelerated approval to ravulizumab (Ultomiris), a C5 complement inhibitor, to reduce proteinuria in adults with primary IgAN at risk of disease progression.
At Kidney Week, the final ORIGIN 3 analysis of atacicept (Trutakna) and 2-year TELIGAN results for telitacicept reported estimated glomerular filtration rate (eGFR) outcomes versus placebo. Interim analyses of povetacicept in RAINIER and sefaxersen in IMAgINATION reported proteinuria reductions, with eGFR data from both trials still pending. The FDA target action date for povetacicept is November 30, 2026.
Additional October coverage included the ATTACK trial of aspirin for primary cardiovascular prevention in chronic kidney disease (CKD), a JAMA study of pregnancy outcomes after living kidney donation, and an interview on the phase 2 TRANSPIRE trial of felzartamab for isolated microvascular inflammation (MVI) in kidney transplant recipients.
The 8 stories below are grouped into regulatory news, IgAN trial data, CKD and cardiovascular prevention, and expert perspective on kidney donation and transplantation. For full meeting coverage, see HCPLive’s ASN Kidney Week 2026 recap.
Regulatory Updates
On October 21, 2026, the FDA granted accelerated approval to AstraZeneca’s ravulizumab to reduce proteinuria in adults with primary IgAN at risk of disease progression. Ravulizumab is a long-acting C5 complement inhibitor given intravenously every 8 weeks after a loading dose. It is the first C5 inhibitor indicated in IgAN.
The approval is based on a prespecified week-34 interim analysis of the phase 3 I CAN trial. In that analysis, 24-hour urine protein-to-creatinine ratio (UPCR) fell 46.6% with ravulizumab and 5.6% with placebo, a 43.4% placebo-adjusted reduction.
IgA Nephropathy Trial Data at Kidney Week 2026
The phase 3 ORIGIN 3 trial randomized 431 adults with biopsy-proven IgAN to weekly subcutaneous atacicept 150 mg or placebo. Atacicept is a dual B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) inhibitor. At week 52, eGFR changed by −0.11 mL/min/1.73 m² with atacicept and −5.69 mL/min/1.73 m² with placebo. Proteinuria decreased 53% with atacicept and 5% with placebo. Kidney disease progression occurred in 5.1% and 17.8% of patients, respectively (HR, 0.24).
The final analysis follows topline results reported in September. On a Kidney Compass episode recorded at Kidney Week, Jonathan Barratt, PhD, FRCP, of the University of Leicester discussed why the eGFR end point was moved from 2 years to week 52 and how APRIL-selective inhibitors compare with dual BAFF/APRIL inhibitors.
An interim analysis of the phase 3 RAINIER trial, published in the New England Journal of Medicine, included 199 adults with IgAN. At week 36, 24-hour UPCR decreased 52.0% with povetacicept, an investigational dual BAFF/APRIL inhibitor from Vertex, and 4.3% with placebo. Galactose-deficient IgA1 (Gd-IgA1) decreased 77.4% with povetacicept and increased 9.1% with placebo.
In a separate RAINIER analysis, 42.2% of patients receiving povetacicept and 6.2% of those receiving placebo reached a UPCR below 0.5 g/g, the target aligned with Kidney Disease: Improving Global Outcomes (KDIGO) guidance. The FDA target action date for povetacicept is November 30, 2026.
Final 2-year results from the phase 3 TELIGAN trial included 318 adults with IgAN. Annualized eGFR change was −0.6 mL/min/1.73 m² per year with telitacicept, a dual BAFF/APRIL inhibitor, and −5.7 mL/min/1.73 m² per year with placebo. Confirmed 30% eGFR decline occurred in 2.5% and 16.4% of patients, respectively (HR, 0.11). Placebo-adjusted UPCR decreased 60.7% at week 104.
Investigator Jicheng Lv, MD, discussed the results on Kidney Compass.
In an interim analysis of the phase 3 IMAgINATION trial, sefaxersen reduced 24-hour UPCR by 43.1% versus placebo at week 37 in 438 patients. Sefaxersen is an investigational once-monthly antisense oligonucleotide from Roche that targets complement factor B.
The trial remains blinded, and 2-year eGFR results are pending.
CKD and Cardiovascular Prevention
The pragmatic, open-label ATTACK trial randomized 4,633 adults with CKD stages G1 to G4 and no history of cardiovascular disease, in UK primary care, to aspirin 75 mg daily or no aspirin. Major cardiovascular events occurred in 2.4% of the aspirin group and 3.3% of the control group, a difference that was not statistically significant (SHR, 0.73; 95% CI, 0.52–1.03). Major bleeding occurred in 29 and 19 patients, respectively.
Enrollment reached 4,633 of a planned 25,000 participants after a pause during the COVID-19 pandemic. Hugh Gallagher, MBBS, PhD, told HCPLive the investigators do not recommend aspirin for primary prevention in CKD based on these results.
Expert Perspective: Kidney Donation and Transplantation
Amit X. Garg, MD, PhD, of Western University discussed a matched cohort study published in JAMA. It compared 385 pregnancies after living kidney donation with 1,540 matched nondonor pregnancies in 3 Canadian provinces. Hypertensive disorders of pregnancy occurred in 11.9% of donor pregnancies and 8.3% of nondonor pregnancies.
Garg said a desire for future pregnancy does not preclude donation. He also discussed counseling donor candidates on the possible increased risk of gestational hypertension or preeclampsia.
Yasir Qazi, MD, a transplant nephrologist at Providence St. Joseph Hospital and an investigator on Biogen’s phase 2 TRANSPIRE trial, discussed isolated MVI in kidney transplant recipients. Isolated MVI occurs without detectable donor-specific antibodies or C4d staining, and no therapy is approved specifically for it.
TRANSPIRE compares felzartamab, an investigational anti-CD38 monoclonal antibody, with placebo for 24 weeks in adults with late isolated MVI. The primary end point is biopsy-proven resolution of MVI, and results are expected in 2028.
