Denver, CO, October 24, 2026: The American Society of Nephrology, has selected the following late breaking clinical trials to be presented in-person at Kidney Week 2026 October 22–25. The selected studies explore a wide range of kidney health issues, including transplantation and dialysis treatment, as well as emerging therapies and regimens to treat kidney diseases and co-morbidities.
- Imlifidase is a desensitization treatment that cleaves all human immunoglobulin G subclasses and eliminates circulating human leukocyte antigen (HLA) antibodies within hours, creating a window of opportunity for highly sensitized patients to undergo transplantation from an otherwise HLA incompatible donor. Imlifidase received a conditional approval in Europe August 2020. In the controlled, non-randomized, open-label post-authorization efficacy and safety trial called PAES, data confirmed that imlifidase is able to convert a positive crossmatch to negative and successfully enable kidney transplantation in highly sensitized patients with excellent graft function at 1 year. “For highly sensitized patients, finding a compatible kidney can be extremely difficult, and many may remain on dialysis for years waiting for a suitable donor. Our study shows that imlifidase can overcome this immunological barrier and enable transplantation, with very encouraging patient and kidney outcomes at 1 year, even though antibody-mediated rejection may develop after transplantation,” said corresponding author Oriol Bestard, MD, PhD, of Vall d’Hebron University Hospital.
Post-Authorization Efficacy and Safety (PAES): An Open-Label Post-Authorization Trial of 50 Imlifidase Crossmatch-Positive Deceased-Donor Kidney Transplants in Europe
- Vitamin D deficiency is common among people on dialysis, but it is unclear whether high doses of vitamin D can prolong life or prevent major health problems in these patients. In the SIMPLIFIED trial, high-dose vitamin D every 2 weeks did not significantly reduce the overall risk of death compared with standard care; however, there was a possible suggestion of benefit in non-white patients and in men. High-dose vitamin D did not significantly reduce cardiovascular-related hospitalizations, infections, or fractures. “These findings do not support population-wide supplementation of high dose vitamin D for individuals on dialysis, but certain groups may benefit and warrant further study,” said corresponding author Rona Smith MD FRCP, of Addenbrooke’s Hospital and the University of Cambridge.
High-Dose Cholecalciferol and Clinical Outcomes in Patients Receiving Dialysis: Results of the SIMPLIFIED Trial
- Aspirin can help prevent cardiovascular disease events in the general population, but the medication increases the risk of bleeding. The ATTACK (Aspirin To Target Arterial events in Chronic Kidney Disease) trial assessed the balance of benefits and harms in people with chronic kidney disease, a patient population at high risk of developing cardiovascular disease. “We found that aspirin may provide an overall net clinical benefit, although we cannot be certain because the trial was substantially smaller than planned,” said corresponding author Hugh Gallagher, MB BS, PhD, of Epsom and St Helier University Hospitals NHS Trust and the University of Southampton. “We are now working with the Antithrombotic Trialists’ Collaboration to combine our results with data from previous studies to determine more definitively the balance of benefits and harms.”
ATTACK (Aspirin To Target Arterial events in Chronic Kidney Disease): A Multicentre Randomised Trial of Aspirin vs. Usual Care for the Primary Prevention of Cardiovascular Events in Patients with CKD
- Anemia is a nearly universal complication of dialysis and an important contributor to the elevated cardiovascular risk experienced by this population. Vadadustat (Vafseo), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in 2024, offers a novel mechanism of action compared with erythropoiesis-stimulating agents (ESAs), which have been the standard treatment for dialysis-related anemia for more than 3 decades. In a pragmatic randomized clinical trial, vadadustat was as effective as ESA therapy in maintaining hemoglobin levels in patients on dialysis, and it was associated with a 16% increase in favorable outcomes, driven primarily by reduced hospitalization rates, with no difference in overall survival. “These findings are consistent with results published earlier this year in the Journal of the American Society of Nephrology, in which daily vadadustat was associated with 14% increase in favorable outcomes compared with the ESA darbepoetin using the same analytical approach,” said corresponding author Geoffrey Block, MD, of US Renal Care Inc.
“Collectively, these data suggest that vadadustat provides effective anemia management while potentially reducing the burden of illness in patients receiving dialysis compared with the current standard of care.”
Vadadustat Three Times Weekly for the Treatment of Anemia in Patients Receiving Hemodialysis
- Complement activation is involved in the aberrant immune system response that contributes to IgA nephropathy. Ravulizumab is a terminal complement inhibitor approved for 4 other indications. An interim analysis through week 34 of the I CAN phase 3, randomized, double-blind, placebo-controlled global study of ravulizumab in adults with primary IgA nephropathy revealed that ravulizumab caused rapid, clinically meaningful and statistically significant reductions in urinary protein-to-creatinine ratio, with favorable effects on hematuria, biomarkers, and remission rates. “The data highlight its potential as a disease-modifying, anti-inflammatory therapeutic option for patients with IgA nephropathy and underscore the important role of terminal complement inhibition as a distinct approach in the overall treatment landscape,” said corresponding author Richard Lafayette, MD, of the Stanford University Medical Center. “We look forward to understanding the potential impact of ravulizumab on estimated glomerular filtration rate when this additional primary endpoint is assessed at week 106.”
Effects of Ravulizumab on Proteinuria and Hematuria in Patients with IgAN: A Prespecified Interim Analysis of the Phase 3 I CAN Trial
- Increased activity of the complement alternative pathway, part of the immune system, has been associated with the pathogenesis of IgA nephropathy. Sefaxersen, is a liver-directed antisense oligonucleotide against factor B (part of the alternative pathway). In the phase 3 IMAgINATION trial, patients with IgA nephropathy received sefaxersen or placebo. The primary endpoint was geometric percentage change from baseline in 24-hour urinary protein-to-creatinine ratio at week 37. The safety, tolerability, and pharmacokinetic and pharmacodynamic profile of sefaxersen were also evaluated. “IMAgINATION is one of the largest trials of an RNA interference therapeutic ever conducted. Sefaxersen, an antisense oligonucleotide that blocks translation of factor B mRNA to protein in the liver, significantly reduced proteinuria in patients with IgA nephropathy,” said corresponding author Jonathan Barratt, MBChB, PhD, FRCP, of the University of Leicester.
Sefaxersen, a Novel mRNA-Targeted Therapy for IgA Nephropathy: Interim Analysis of the Phase 3 IMAgINATION Trial
The phase 3 Symptom monitoring WIth Feedback Trial (SWIFT) tested the impact of regular symptom assessment on quality of life in adults receiving maintenance hemodialysis. Investigators found that compared with patients who received usual care, those who also had their symptoms regularly assessed and were asked for feedback by clinic staff did not experience improvements in health-related quality of life related to mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and fatigue at 12 months “Symptom monitoring and feedback increased symptom conversations between nephrologists and their hemodialysis patients but did not improve overall health-related quality of life or fatigue. Routine patient-reported outcomes collection alone is insufficient; integrated, resourced, and effective symptom-management pathways are needed,” said principal investigator Rachael Morton, PhD, of the University of Sydney, Australia.
SWIFT: A Phase 3 Cluster-Randomized Registry Trial of Symptom Monitoring vs. Usual Care in Patients with Hemodialysis
- A phase 2 clinical trial tested the potential of an experimental drug called HLX79/E-602 (efgitasialase alpha) for removing protective sugar molecules (sialic acid) from immune cells that injure the kidneys to cause membranous nephropathy. Removing sialic acid helps other immune therapies such as rituximab destroy these immune cells. Compared with rituximab alone, rituximab + 10 mg/kg HLX79/E-602, and rituximab + 20 mg/kg HLX79/E-602, rituximab + 30 mg/kg HLX79/E-602 produced the fastest, most complete response. “Current treatments for membranous nephropathy can take 6 months or more to work, if they work at all. HLX79/E-602 takes a new approach by removing the sialic acid that helps disease-driving immune cells persist,” explained senior author Brad Rovin, MD, of The Ohio State University. “In this randomized controlled trial, we found that compared with standard-of-care rituximab alone, patients treated with rituximab plus HLX79/E-602 achieved more complete and partial responses, responded faster, and the combination was well tolerated.”
HLX79 (E-602) Plus Rituximab Produces Fast and Durable Responses in Patients with Membranous Nephropathy
