Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Amgen Inc. is conducting a Phase 3 clinical study titled ‘Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis.' The study aims to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of etelcalcetide in treating secondary hyperparathyroidism in pediatric patients undergoing hemodialysis due to chronic kidney disease. This research is significant as it addresses a critical need for effective treatments in this vulnerable population.
The intervention being tested is Etelcalcetide, a drug already approved for adult patients with secondary hyperparathyroidism on hemodialysis. It works by controlling levels of intact parathyroid hormone, calcium, and phosphorus, aiming to improve patient outcomes.
The study follows an interventional design with a single-group model. There is no allocation or masking involved, meaning all participants receive the treatment, and the primary purpose is treatment-focused. Participants will receive Etelcalcetide intravenously three times a week, with doses adjusted based on specific health markers over a 26-week period.
The study began on December 20, 2019, with an ongoing recruitment phase. The latest update was submitted on July 15, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results and regulatory decisions.
The outcome of this study could significantly impact Amgen’s stock performance and investor sentiment, given the potential expansion of Etelcalcetide’s use to a younger demographic. This could strengthen Amgen’s position in the market, especially against competitors focusing on similar treatments for chronic kidney disease-related conditions.
The study is currently ongoing, with further details available on the ClinicalTrials portal.