U.S. Renal Care Enrolled First Patients in the VOICE Collaborative Clinical Trial of Vafseo® (vadadustat) for CKD Patients on Dialysis
Akebia Therapeutics (Nasdaq: AKBA) announced that U.S. Renal Care has enrolled the first patients in the VOICE collaborative trial for Vafseo (vadadustat). The study will evaluate Vafseo's safety and efficacy when administered three times weekly to dialysis patients, comparing it to standard-of-care treatments. The trial aims to enroll approximately 2,200 patients and will assess non-inferiority for all-cause mortality as primary endpoint and superiority in reducing all-cause hospitalization as secondary endpoint. Vafseo, approved by the FDA in March 2024 for anemia in CKD patients on dialysis, is expected to launch in January 2025.
Akebia Therapeutics (Nasdaq: AKBA) ha annunciato che U.S. Renal Care ha arruolato i primi pazienti nel trial collaborativo VOICE per Vafseo (vadadustat). Lo studio valuterà la sicurezza e l'efficacia di Vafseo quando somministrato tre volte a settimana a pazienti in dialisi, confrontandolo con i trattamenti standard. Il trial prevede di arruolare circa 2.200 pazienti e valuterà la non inferiorità per mortalità per tutte le cause come obiettivo primario e la superiorità nella riduzione della ospedalizzazione per tutte le cause come obiettivo secondario. Vafseo, approvato dalla FDA a marzo 2024 per l'anemia nei pazienti con CKD in dialisi, è previsto in lancio a gennaio 2025.
Akebia Therapeutics (Nasdaq: AKBA) anunció que U.S. Renal Care ha inscrito a los primeros pacientes en el ensayo colaborativo VOICE para Vafseo (vadadustat). El estudio evaluará la seguridad y eficacia de Vafseo cuando se administre tres veces por semana a pacientes en diálisis, comparándolo con los tratamientos estándar. El ensayo tiene como objetivo inscribir aproximadamente 2,200 pacientes y evaluará la no inferioridad de la mortalidad por todas las causas como punto final primario y la superioridad en la reducción de las hospitalizaciones por todas las causas como punto final secundario. Vafseo, aprobado por la FDA en marzo de 2024 para la anemia en pacientes con CKD en diálisis, se espera que se lance en enero de 2025.
Akebia Therapeutics (Nasdaq: AKBA)는 미국 신장 치료 센터가 Vafseo (vadadustat) 의 VOICE 협력 시험에 첫 번째 환자를 모집했다고 발표했습니다. 이 연구는 Vafseo를 주 3회 투여하는 경우의 안전성과 효과를 평가하며, 표준 치료와 비교합니다. 이 시험은 약 2,200명의 환자를 모집할 계획이며, 주요 목표로 모든 원인에 대한 사망의 비열등성을 평가하고, 부차적인 목표로 모든 원인에 대한 입원의 감소에서 우월성을 평가합니다. Vafseo는 2024년 3월 CKD 환자의 빈혈에 대해 FDA의 승인을 받은 후 2025년 1월에 출시될 예정입니다.
Akebia Therapeutics (Nasdaq: AKBA) a annoncé qu'U.S. Renal Care a recruté les premiers patients dans le cadre de l'essai collaboratif VOICE pour Vafseo (vadadustat). L'étude évaluera la sécurité et l'efficacité de Vafseo lorsqu'il est administré trois fois par semaine à des patients sous dialyse, en le comparant aux traitements standards. L'essai vise à recruter environ 2 200 patients et évaluera la non-infériorité en termes de mortalité toutes causes confondues comme critère principal et la supériorité dans la réduction des hospitalisations toutes causes confondues comme critère secondaire. Vafseo, approuvé par la FDA en mars 2024 pour l'anémie chez les patients atteints de MRC sous dialyse, devrait être lancé en janvier 2025.
Akebia Therapeutics (Nasdaq: AKBA) gab bekannt, dass U.S. Renal Care die ersten Patienten in die VOICE-Kooperationsstudie für Vafseo (vadadustat) eingeschrieben hat. Die Studie wird die Sicherheit und Wirksamkeit von Vafseo bewerten, wenn es dreimal pro Woche an Dialysepatienten verabreicht wird, im Vergleich zu Standardbehandlungen. Die Studie hat zum Ziel, etwa 2.200 Patienten einzuschreiben und wird die Nicht-Unterlegenheit hinsichtlich der Gesamtsterblichkeit als primären Endpunkt sowie die Überlegenheit bei der Reduzierung der Gesamtkrankenhauseinweisungen als sekundären Endpunkt bewerten. Vafseo, das von der FDA im März 2024 zur Behandlung von Anämie bei CKD-Patienten in Dialyse genehmigt wurde, wird voraussichtlich im Januar 2025 auf den Markt kommen.
- FDA approval received for Vafseo in March 2024
- Commercial launch planned for January 2025
- Large-scale trial with 2,200 patients demonstrates significant investment in product development
- Product not yet commercially available
- Must prove non-inferiority against existing treatments
- to patients who have been on dialysis for at least three months
Insights
The initiation of patient enrollment in the VOICE trial represents a significant milestone for Akebia's Vafseo commercialization strategy. The 2,200-patient study will evaluate a novel three-times-weekly dosing regimen, which could offer operational advantages over the approved once-daily dosing. The trial's focus on mortality and hospitalization outcomes could potentially differentiate Vafseo from current standard-of-care treatments.
The timing aligns strategically with the planned January 2025 commercial launch. The study's design to demonstrate non-inferiority in mortality and potential superiority in reducing hospitalizations could significantly impact market adoption if positive. This large-scale outcomes trial could provide important real-world evidence to support reimbursement decisions and market positioning against established ESA treatments.
This development strengthens Akebia's market position in the $3.5 billion U.S. dialysis anemia market. The collaboration with U.S. Renal Care, one of the largest dialysis providers, is strategically important for market penetration. The three-times-weekly dosing schedule, if successful, could improve patient compliance and reduce administration burden, potentially driving better market adoption.
The timing of the study initiation, ahead of the January 2025 launch, indicates strong commercial execution. The focus on real-world outcomes could help secure favorable coverage from payers and drive market share gains. This positions Vafseo to potentially capture significant market share from established ESA treatments in the dialysis segment.
Outcomes study will assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care
"We look forward to begin treating CKD anemia patients on dialysis with Vafseo ahead of its anticipated market launch in January 2025," said Steven K. Burke, M.D., Chief Medical Officer of Akebia. "The study has been designed to evaluate Vafseo safety and efficacy when dosed three times a week to align with patients' current dialysis schedule as well as to explore additional potential patient benefits. We congratulate Dr. Geoff Block and his team at USRC on quickly consenting patients for the study and thank him for his commitment to patients impacted by kidney disease."
Vafseo was approved by the
The VOICE trial intends to enroll approximately 2,200 patients who will be randomized to oral Vafseo 300 mg tablets administered three times per week or standard-of-care erythropoiesis-stimulating agents. The trial will end approximately 18 months after the last patient is randomized. The primary endpoint is non-inferiority for all-cause mortality and the secondary endpoint will test superiority of Vafseo to reduce all-cause hospitalization. More information about the VOICE trial can be found here.
About
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
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
- Hypertension
Worsening of hypertension was reported in
- Seizures
Seizures occurred in
- Gastrointestinal (GI) Erosion
Gastric or esophageal erosions occurred in
- 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
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 expectations regarding the VOICE trial, including expectations as to the potential benefits and risks of Vafseo when dosed three times a week in dialysis patients, and Akebia's expectations as to the timing of the market availability of Vafseo in the U.S. 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: whether Vafseo will be commercially available when expected; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; the results of preclinical and clinical research; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Vafseo; the competitive landscape for Vafseo; the ability of Akebia to attract and retain qualified personnel; decisions made by health authorities, such as the FDA, with respect to regulatory filings; the direct or indirect impact of the COVID-19 pandemic on the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; and early termination of any of Akebia's collaborations. 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 September 30, 2024, 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
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SOURCE Akebia Therapeutics, Inc.
FAQ
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