Setanaxib

The annual meeting of the American Society of Nephrology (Kidney Week) was held this year from Nov. 5 to 9 in Houston, attracting attendees from around the world, including nephrology specialists, researchers, scientists, and other health care professionals. The conference featured presentations focusing on the latest advances in the management of patients with kidney diseases and related disorders. In one study, Daniel Gale, Ph.D., of University College London, and colleagues showed that an NADPH oxidase synthase (NOX) 1/4 inhibitor, setanaxib, has an acceptable safety profile, with some evidence of reduced proteinuria among patients with Alport syndrome. The researchers analyzed the safety and efficacy of setanaxib in Alport syndrome. In a 2:1 randomized controlled trial of 20 patients, 24 weeks of treatment was well tolerated, and there was some evidence of reduced proteinuria in the treatment group compared with placebo. The study was a small phase 2a exploratory study and none of the differences observed were statistically significant. "We conclude that these results justify a further (larger and longer) randomized controlled study to quantify the safety and efficacy of this drug to treat people with Alport syndrome," Gale said. The study was funded by Calliditas Therapeutics, which is developing setanaxib. Abstract No. SA-OR082 In another study, Charmaine E. Lok, M.D., of the University Health Network in Toronto, and colleagues found that daily oral supplementation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the form of fish oil is safe and reduces the rate of serious cardiovascular events in patients with kidney failure on maintenance hemodialysis. As part of the PISCES study, 1,228 patients who were treated with chronic hemodialysis were randomly assigned to oral daily fish oil or placebo capsules. The investigators found that the rate of serious cardiovascular events (heart attack, stroke, peripheral vascular disease leading to amputation, and cardiac death) was reduced by approximately 40 percent in patients treated with maintenance hemodialysis who received daily oral supplementation of 4 g of fish oil (total EPA, 1.6 g; total DHA, 0.8 g) compared with placebo. The rate of serious cardiovascular events was 0.31/1,000 days in the fish oil group versus 0.61/1,000 days in the placebo group. Adverse events, including bleeding, did not differ between the groups. "Given the underlying high risk of cardiovascular events, lack of other preventative measures, and safety of fish oil, I would not be surprised if there is quick uptake of fish oil supplementation in patients receiving hemodialysis," Lok said. "It should be emphasized that the dose and formulation of fish oil, and how it is taken, is important." Abstract No. FR-OR082 Natalie Staplin, Ph.D., of the University of Oxford Medical Sciences Division in the United Kingdom, and colleagues demonstrated clear absolute benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors on kidney, hospitalization, and mortality outcomes irrespective of diabetes status and level of urine albumin-to-creatinine ratio. The authors conducted a meta-analysis of 58,816 participants enrolled in eight large randomized trials of SGLT2 inhibitors, including empagliflozin, dapagliflozin, and canagliflozin, compared with placebo. The investigators found that SGLT2 inhibitors substantially reduced the risks for kidney disease progression, acute kidney injury, hospitalization, and death among individuals with and without diabetes and across all levels of albuminuria. Compared with placebo, allocation to SGLT2 inhibition reduced the hazard of kidney disease progression by 35 percent among participants with diabetes and 26 percent among participants without diabetes. Allocation to SGLT2 inhibition reduced the risk for acute kidney injury to a similar extent in participants with and without diabetes by 23 and 28 percent, respectively. The risk for hospitalization for heart failure was 32 and 25 percent lower in people with and without diabetes, respectively, who were allocated to an SGLT2 inhibitor, and the risk for any hospitalization was reduced by 10 and 11 percent, respectively. People with lower albumin levels, who are often at lower risk for kidney failure, experienced benefit as a result of taking an SGLT2 inhibitor, particularly through reduced hospital admissions for heart failure and any other cause. Participants with higher albuminuria (≥200 mg/g) had larger absolute reductions in kidney disease progression. "The findings suggest that guideline recommendations distinguishing between patients based on diabetes status or albuminuria level may no longer be necessary," Staplin said. "Current international kidney disease guidelines give stronger recommendations for using SGLT2 inhibitors in patients with high albumin levels, but the new results indicate that all patients with chronic kidney disease can benefit." Abstract No. FR-OR086 In the multicenter, randomized OPTIMIZE trial, Stefan P. Berger, Ph.D., of the Universitair Medisch Centrum Groningen in the Netherlands, and colleagues found that a reduced-dose immunosuppressive regimen combining low-dose tacrolimus plus everolimus is safe among older kidney transplant recipients (age 65 years and older), but the regimen does not lead to improved outcomes compared with the current standard regimen. The authors investigated whether older kidney transplant recipients could benefit from a reduced and less nephrotoxic immunosuppressive regimen. Three hundred seventy-nine kidney transplant recipients aged 65 years or older, across six Dutch university medical centers and the University Hospitals Leuven, were included in the study. The study compared a "standard" immunosuppressive regimen (prednisolone + standard-dose tacrolimus + mycophenolate mofetil) versus an "adapted" regimen (prednisolone + low-dose tacrolimus + everolimus). The primary outcome was defined as a "successful transplantation" at two years: patient alive with functioning graft and minimum estimated glomerular filtration rate thresholds (≥30 mL/min/1.73m 2 for older deceased-donor kidneys; ≥45 mL/min/1.73m 2 for younger deceased donor or living donor kidneys). At two years, the authors observed no statistically significant difference between arms -- 50 percent success in the low-dose arm versus 57 percent in the standard-dose arm. "Importantly, the adapted regimen was safe, but it did not demonstrate superiority over the standard regimen in this older population," Berger said. "Clinicians should be reassured that older transplant recipients achieve very good outcomes under current standard regimens (89 percent patient survival; only 5 to 6 percent graft loss at two years) and that a reduced regimen is safe. We should move toward stratified immunosuppression in older patients with an awareness that immunosuppression can be reduced safely in most cases. Clearly the OPTIMIZE trial had not hit the threshold for reduction of immunosuppression. The study highlights the need for further research to tailor the immunosuppressive regimen to the individual older patient (taking into account donor age, immunosenescence, comorbidities, frailty, etc.)." The study was funded by Chiesi Pharmaceuticals. Abstract No. FR-OR085 ASN: Nearly All Adults With CKD Would Benefit from Systolic BP Target <120 mm Hg WEDNESDAY, Nov. 12, 2025 -- Nearly all adults with chronic kidney disease would benefit from a systolic blood pressure target <120 versus <140 mm Hg, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Similar Risks Seen for Young, Older Patients With Primary Glomerular Diseases WEDNESDAY, Nov. 12, 2025 -- For patients with primary glomerular diseases, young patients face similar risks of kidney function decline as older patients, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Expanding Kidney Transplant Wait-List Criteria to Include Risk for Kidney Failure Could Improve Outcomes WEDNESDAY, Nov. 12, 2025 -- Expanding the wait-listing criteria for kidney transplantation to include risk for kidney failure -- rather than taking a single measurement of kidney function -- could improve outcomes, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: New Tool Predicts CKD Survival With Conservative Management Versus Dialysis WEDNESDAY, Nov. 12, 2025 -- A new tool can predict individualized probability of survival with conservative management versus dialysis transition among individuals with advanced chronic kidney disease, according to a study presented at Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Large Gap Between Creatinine-Based eGFR and Cystatin C-Based eGFR Tied to Worse Outcomes MONDAY, Nov. 10, 2025 -- In the outpatient setting, the presence of a cystatin C-based estimated glomerular filtration rate that is at least 30 percent lower than creatinine-based eGFR is associated with significantly higher rates of all-cause mortality, cardiovascular events, and kidney failure, according to a study published online Nov. 7 in the Journal of the American Medical Association to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text ASN: Prevalence of Chronic Kidney Disease Increasing Globally MONDAY, Nov. 10, 2025 -- The prevalence of chronic kidney disease is increasing globally, according to a study published online Nov. 7 in The Lancet to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 9 in Houston. Read Full Text

STOCKHOLM, Nov. 10, 2025 /PRNewswire/ -- Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that primary safety endpoints of a Phase 2a, randomized, double-blind, placebo-controlled trial of setanaxib in patients with Alport syndrome were presented in a High-Impact Clinical Trials session at the American Society of Nephrology Kidney Week in Houston, Texas, on Saturday, November 8. Alport syndrome is a rare genetic kidney disease resulting from mutations in collagen type IV genes that can lead to progressive loss of kidney function and end-stage kidney disease. This Phase 2a trial (NCT06274489) enrolled 20 patients aged 12-40 years with genetically confirmed Alport syndrome, a urine protein-creatinine ratio (UPCR) of ≥ 0.8 g/g, and an estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m². Patients were randomized 2:1 to receive oral setanaxib (800 mg BID [18-40 years]/800 + 400 mg/day [12-17 years], n=13; or placebo, n=7) plus background therapy for 24 weeks, with a four-week follow-up period on background therapy alone. The primary endpoints were serious adverse events (SAEs) and adverse events of special interest (AESIs); secondary endpoints included the change in UPCR and eGFR from baseline. The primary safety endpoints were met with AEs occurring at similar frequencies in both treatment groups, and no AESIs were reported. One SAE was reported for a patient in the setanaxib group that was not deemed treatment-related. Patients receiving setanaxib had a 15% mean reduction in UPCR at 24 weeks and a 27% mean reduction in UPCR at four weeks post-dosing compared to placebo. At Week 24, two patients (15.4%) in the setanaxib group achieved a ≥25% reduction in UPCR from baseline, compared with none in the placebo group. There was a 5% mean reduction in eGFR with setanaxib at 24 weeks and a 4% reduction at four weeks post-dosing versus placebo. Further research is needed to investigate setanaxib's clinical efficacy and confirm its benefit/risk profile in a larger Alport syndrome patient population. "These findings represent an important step toward establishing the safety of setanaxib in patients with Alport syndrome, an underserved patient group for whom no approved therapies currently exist," said Professor Daniel Gale of Royal Free Hospital, London, who presented the findings. About setanaxib Setanaxib is a novel enzyme-dependent hydrogen peroxide-depleting agent with anti-fibrotic and anti-inflammation properties. Setanaxib is in development for rare diseases such as Alport syndrome, where targeting inflammation and fibrosis may potentially slow disease progression. About Calliditas Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit Calliditas.com for further information. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Healthcare, Homes, and Material. Its Healthcare operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit asahi-kasei.com. SOURCE Calliditas Therapeutics 21% more press release views with Request a Demo