Akebia Therapeutics ((AKBA)) announced an update on their ongoing clinical study.
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Study Overview: Akebia Therapeutics is conducting a study titled A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis. The study aims to assess the effectiveness of vadadustat, administered three times a week, against the standard erythropoiesis-stimulating agent (ESA) in treating anemia in patients undergoing in-center hemodialysis due to end-stage kidney disease (ESKD). This study is significant as it explores potential improvements in anemia management for CKD patients.
Intervention/Treatment: The study tests two interventions: Vadadustat, an oral tablet administered three times weekly, and the standard ESA, delivered via intravenous infusion. Vadadustat is being evaluated for its efficacy in maintaining hemoglobin levels compared to the traditional ESA treatment.
Study Design: This Phase 3 study is interventional, with participants randomly assigned to either the vadadustat or ESA group. It follows a parallel intervention model and is open-label, meaning both researchers and participants know which treatment is being administered. The primary purpose is treatment-focused, aiming to improve anemia management in CKD patients.
Study Timeline: The study began on March 27, 2025, with the last update submitted on August 15, 2025. These dates are crucial as they indicate the study’s progression and current status, which is recruiting. The primary completion and estimated completion dates are yet to be announced.
Market Implications: This study update could influence Akebia Therapeutics’ stock performance positively if vadadustat proves more effective than ESA, potentially increasing investor interest. The outcome may also impact the competitive landscape in the CKD treatment market, where other companies are developing similar therapies.
The study is ongoing, and further details are available on the ClinicalTrials portal.