Akebia Therapeutics Announces Five Presentations at ASN Kidney Week 2025

Rhea-AI Summary

Akebia Therapeutics (Nasdaq: AKBA) will present five scientific items at ASN Kidney Week 2025 in Houston, Nov 5-9, 2025, and staff the company booth #903.

Highlights include an oral win‑odds analysis of all‑cause mortality and hospitalization from the global Phase 3 INNO2VATE trials (presenter: Glenn M. Chertow, MD) on Nov 6, 2025, 4:30–6:00 PM CT, Room 351D, and four Akebia‑supported posters on Nov 6–7 covering model‑based starting dose recommendations for Vafseo (vadadustat), dosing consistency vs darbepoetin, and two ongoing real‑world randomized studies (VOICE and VOCAL) assessing three‑times‑weekly vadadustat in dialysis patients. Vafseo is approved in the U.S. for anemia in adults on dialysis ≥3 months.

Insights

Clinical development expert

Akebia will present trial and real‑world vadadustat data at ASN Kidney Week; results may inform clinical use but none are reported here.

The announcement outlines multiple planned presentations, including a win‑odds analysis of all‑cause mortality and hospitalization from the INNO2VATE Phase 3 program and four posters on dosing and ongoing real‑world studies (VOICE and VOCAL). This set of presentations advances the clinical evidence agenda by sharing analyses from randomized trials and pragmatic studies that directly relate to safety and dosing of Vafseo (vadadustat).

Key dependencies and risks include the actual content of the presented results and statistical robustness; the release contains no numeric outcomes or conclusions, so no efficacy or safety implications can be drawn from this notice alone. Watch for the oral session on November 6, 2025 and poster sessions on November 6–7, 2025 for concrete endpoints, effect sizes, and subgroup findings that would materially affect clinical interpretation over the near term.

Presentations Detail Ongoing Vafseo® (Vadadustat) Real-World Studies and Explore Insights Regarding Clinical Benefits and Dosing of Vafseo

CAMBRIDGE, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics^®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the American Society of Nephrology Kidney Week 2025 (ASN Kidney Week), which will take place in Houston, TX from November 5-9, 2025. ASN Kidney Week attendees can also visit Akebia at Booth #903 in the Exhibit Hall.

Dr. Glenn M. Chertow of Stanford University will present the results of a win odds analysis of all-cause mortality and hospitalization from the INNO₂VATE trials, part of the global Phase 3 clinical development programs for vadadustat. In the U.S., Vafseo^® (vadadustat) is approved for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Additionally, four posters will present data to inform dosing of vadadustat as well as information on ongoing real-world evidence studies, including the VOICE and VOCAL trials.

“We remain actively engaged with the nephrology community as we conduct multiple clinical real-world evidence studies and identify potential additional clinical benefits of Vafseo,” said Steven Burke, MD, Senior Vice President and Chief Research & Development Officer at Akebia. “Generating, evaluating and sharing data are critical to ensuring healthcare providers have the information they need to make informed decisions about treating patients with Vafseo and to further the medical and scientific communities’ understanding about this new, innovative medicine.”

Oral presentation details:

Win-Odds Analysis of Deaths and Hospitalization in Patients taking Vadadustat or Darbepoetin Alfa for CKD-Related Anemia Undergoing Dialysis
Presenter: Glenn M. Chertow, MD
Session Title: Hemodialysis: Novel Interventions
Session Date/Time: November 6, 2025; 4:30 PM to 6:00 PM
Session Room: Room 351D (Convention Center)

Akebia-supported posters to be presented at ASN Kidney Week 2025 in the Exhibit Hall:

Model-Based VAFSEO Starting Dose Recommendations in Dialysis-Dependent CKD Patients
Poster #: TH-PO902
November 6, 2025; 10:00 AM-12:00 PM CDT

Vadadustat Outcomes In-Center Experience (VOICE) Study: Pragmatic Randomized Controlled Trial to Test the Safety of Three Times Weekly Vadadustat
Poster #: FR-PO0204
November 7, 2025; 10:00 AM-12:00 PM CDT

Consistency of the Estimate of Responsiveness of Vadadustat vs. Darbepoetin
Poster #: FR-PO0202
November 7, 2025; 10:00 AM-12:00 PM CDT

Three Times Weekly In-Center Vadadustat vs. Standard of Care Erythropoiesis-Stimulating Agent (ESA) for Treatment of CKD-Related Anemia in Patients Undergoing Dialysis (VOCAL)
Poster #: INFO10-FR
November 7, 2025; 10:00 AM-12:00 PM CDT

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 Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, 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.
• 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 regarding: Akebia’s plans and expectations with respect to its ability to identify potential additional clinical benefits of Vafseo; and Akebia’s beliefs that generating, evaluating and sharing data are critical to ensuring healthcare providers have the information they need to make informed decisions about treating patients with Vafseo and to further the medical and scientific communities’ understanding about this new, innovative medicine. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "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 Vafseo; the results of preclinical and clinical research; 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, Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Vafseo, including generic entrants and the timing thereof; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and other filings that Akebia may make with the U.S. Securities and Exchange Commission 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

FAQ

When and where will Akebia (AKBA) present Vafseo data at ASN Kidney Week 2025?

Akebia presentations occur at ASN Kidney Week in Houston, Nov 5–9, 2025; the oral session is Nov 6, 2025, 4:30–6:00 PM CT in Room 351D and posters are Nov 6–7 in the Exhibit Hall.

What will Glenn M. Chertow present about vadadustat (Vafseo) at ASN Kidney Week 2025?

Dr. Glenn M. Chertow will present a win‑odds analysis of all‑cause mortality and hospitalization from the Phase 3 INNO2VATE trials on Nov 6, 2025.

Which Akebia poster covers starting dose recommendations for Vafseo (vadadustat) and when is it shown?

The model‑based Vafseo starting dose recommendations poster (TH‑PO902) will be shown Nov 6, 2025, 10:00 AM–12:00 PM CDT in the Exhibit Hall.

What are the VOICE and VOCAL studies listed by Akebia at ASN Kidney Week 2025?

VOICE is a pragmatic randomized controlled trial testing three‑times‑weekly vadadustat safety; VOCAL compares three‑times‑weekly in‑center vadadustat versus standard ESA in dialysis patients; both have posters on Nov 7, 2025.

Is Vafseo (vadadustat) approved for dialysis patients in the U.S.?

Yes; Vafseo is approved in the U.S. to treat anemia due to chronic kidney disease in adults receiving dialysis for at least three months.

How can investors access Akebia's ASN Kidney Week materials or booth information?

Attendees can visit Akebia at Booth #903 in the Exhibit Hall during ASN Kidney Week 2025; presentation schedules and poster numbers are listed in the conference program.