Vadadustat

Vadadustat demonstrated a clinically meaningful safety outcome benefit in U.S. patients with anemia due to CKD on dialysis utilizing TIW dosing regimen WALTHAM, Mass., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease announced that U.S. Renal Care (USRC), the nation’s largest privately held and fastest-growing kidney care provider, presented data from the Vafseo Outcomes In Center Experience (VOICE) trial during a late-breaking session at American Society of Nephrology Kidney Week 2026 (ASN Kidney Week). The presentation highlighted findings of significantly improved safety outcomes in patients treated with vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) dosed three times weekly (TIW) versus an erythropoiesis-stimulating agent (ESA). Additional data showed more stable hemoglobin control and fewer serious adverse events in the patients treated with vadadustat. In March 2024, Vafseo ® (vadadustat), was approved by the U.S. Food and Drug Administration for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months, and it has been available in the U.S. since January 2025. Vafseo is approved for once-daily administration. There are no other oral HIF-PHIs to treat anemia in the market or in development in the U.S. “The VOICE trial was designed to test the hypothesis that an innovative treatment for anemia in patients on dialysis could deliver more than just hemoglobin management, but rather could deliver clinically meaningful outcomes versus ESA,” said Geoffrey A. Block, M.D., FASN, Associate Chief Medical Officer and Senior Vice President, Clinical Research & Medical Affairs for USRC. “The VOICE trial data demonstrated that treatment with vadadustat resulted in a statistically significant reduction in the primary composite endpoint of all-cause mortality and hospitalization, with the results driven by a reduction in hospitalization, versus patients treated with ESA. Further, we observed that patients treated with vadadustat experienced fewer high hemoglobin excursions and lower ESA rescue versus patients treated with ESA, both clinically meaningful outcomes. We’re extremely pleased that the data validated our understanding of the potential clinical benefit of vadadustat, which we believe positions vadadustat to become a new standard of care. We are grateful to the thousands of patient volunteers who have participated, as well as, the USRC Kidney Research team, investigators, and the staff at participating facilities, all without whom we would not have been able to complete this meaningful trial.” The VOICE trial enrolled 2,116 patients and was designed as a randomized, open-label, active-controlled, noninferiority trial sponsored by USRC to measure the safety of vadadustat administered TIW versus standard-of-care ESA using a hierarchical composite endpoint of mortality and hospitalization rates. The trial demonstrated a win odds of 1.16 (95% confidence interval (CI) 1.06, 1.28, p=0.0016), establishing non-inferiority and superiority of the primary composite endpoint. Further, the data demonstrated: The hospitalization rate was 10% lower in patients treated with vadadustat versus ESA. There was a statistically significant decrease in hospitalization rate with vadadustat versus ESA (111.1 versus 123.1 hospitalizations per 100 patient-years, incidence rate ratio of 0.90 (95% CI, 0.82, 0.99). There was no statistically significant difference between mortality rates with vadadustat versus ESA (8.8% versus 8.8% per 100 patient-years, incidence rate ratio of 1.00 (95% CI 0.72, 1.39). Exposure-adjusted serious adverse events were lower with vadadustat versus ESA. Patients treated with vadadustat experienced 121.5 events per 100 patient-years compared to 134.2 events per 100 patient-years for patients treated with ESA. Vadadustat improved hemoglobin control versus ESA. High hemoglobin (HgB) excursions were less common in patients treated with vadadustat compared to ESA. The reduction in excursions for patients treated with vadadustat versus ESA were as follows: a 64% reduction in the odds of a HgB above 12 g/dL (29.6% vs. 51.2%, p<0.0001), a 57% reduction in the odds of a HgB above 13 g/dL (6.4% vs. 12.7%, p<0.0001), and 61% reduction in the odds of a HgB above 14 g/dL (1.6% vs. 3.2%, p=0.0044). There was no overall difference in low excursions (below 9, 8, or 7 g/dL). The odds of ESA rescue were 28% less likely with vadadustat versus ESA (44.6% vs. 52.8%, p=0.0006). About the VOICE Trial The Vafseo Outcomes In-Center Experience (VOICE) trial, a collaborative trial between U.S. Renal Care and Akebia Therapeutics, is an investigator-initiated, multi-center, randomized, open-label, active-controlled, non-inferiority trial of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with end stage kidney disease. The primary endpoint is a composite hierarchical endpoint of all-cause mortality and all-cause hospitalization, analyzed by the win odds method. The secondary endpoints are all-cause hospitalization and all-cause mortality. Please refer to NCT06520826 on for more information about the VOICE trial. About U.S. Renal Care U.S. Renal Care is the largest privately held and fastest-growing dialysis provider in the nation. We partner with nephrologists to care for more than 37,000 people living with kidney disease across 32 states, offering in-center and home dialysis options that support each patient’s unique lifestyle and care needs. U.S. Renal Care leads the dialysis industry with the highest percentage of CMS 4- and 5-star rated centers for patient experience and quality of care. U.S. Renal Care’s Kidney Research team designs and conducts clinical trials, spanning across academic collaboration, investigator-initiated research, industry-sponsored research, and federally-funded research. Since 2000, U.S. Renal Care has grown through clinical excellence, innovation and a shared commitment to improving the lives of people with kidney disease. Visit USRenalCare.com to learn more. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Waltham, Massachusetts. For more information, please visit our website at , which does not form a part of this release. About Vafseo ® (vadadustat) tablets Vafseo ® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries. INDICATION VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. In patients with anemia due to CKD not on dialysis. IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. CONTRAINDICATIONS Known hypersensitivity to VAFSEO or any of its components Uncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. Hepatotoxicity Hepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. Hypertension Worsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. Seizures Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency. Gastrointestinal (GI) Erosion Gastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. Malignancy VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. DRUG INTERACTIONS Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron. Non-iron-containing phosphate binders : Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders. BCRP substrates : Monitor for signs of substrate adverse reactions and consider dose reduction. Statins : Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. A pregnancy exposure registry is available to monitor outcomes in women exposed to VAFSEO during pregnancy. Report pregnancies to 1-844-445-3799. Lactation: Breastfeeding not recommended until two days after the final dose. Hepatic Impairment : Not recommended in patients with cirrhosis or active, acute liver disease. Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. Forward-Looking Statements Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to: statements made by Geoffrey A. Block in this press release, including the hypothesis that vadadustat could deliver hemoglobin management as well as clinically meaningful outcomes versus ESA, beliefs that patients experiencing fewer high hemoglobin excursions and lower ESA rescue when treated with vadadustat versus ESA as observed in the VOICE trial represent clinically meaningful outcomes, beliefs and understandings regarding the potential clinical benefit of vadadustat and the extent it is positioned to become a new standard of care. The terms "intend," "believe," "plan," "goal," "potential," "anticipate,” "estimate," “target,” “predict,” "expect," "future," “may,” "will," “could,” "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; risks and uncertainties related to Akebia’s ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing of such preclinical studies and clinical trials; the results of Akebia’s preclinical studies and clinical trials, including that initial, preliminary, interim or retrospective data, analysis or results may not be replicated in, or predictive of, final analyses or results of future preclinical or clinical data, analyses or results or that such analysis or results may not support further development of such product candidates; Akebia’s ability to initiate and enroll patients in its clinical trials; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Akebia’s commercial products, including estimates regarding the potential market opportunity; the competitive landscape for Akebia’s commercial products, including generic entrants and the timing thereof; Akebia’s ability to obtain and maintain patent protection on its products and product candidates, and to successfully defend these patents against third-party challenges; Akebia’s ability to attract and retain qualified personnel; Akebia's ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; Akebia’s revenue and that its financial results from prior periods may not be indicative of future results; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia's collaborations; and changes in the geopolitical environment and uncertainty surrounding U.S. trade policy on tariffs. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC), and other filings that Akebia may make with the SEC in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Akebia Therapeutics ® and Vafseo ® are registered trademarks of Akebia Therapeutics, Inc. Akebia Therapeutics Contact Mercedes Carrasco mcarrasco@akebia.com