Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.
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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 with chronic kidney disease on hemodialysis.
The intervention being tested is the drug Etelcalcetide, which is administered intravenously. It is designed to manage secondary hyperparathyroidism by controlling levels of intact parathyroid hormone, calcium, and phosphorus. Etelcalcetide is already approved for use in adult patients with similar conditions.
This interventional study follows a single-group assignment model without masking, focusing on treatment as the primary purpose. Participants receive a starting dose of etelcalcetide, which is adjusted every four weeks based on specific health markers, over a period of 26 weeks.
The study began on May 29, 2019, and is currently recruiting participants. The last update was submitted on October 15, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
The outcome of this study could significantly influence Amgen’s stock performance and investor sentiment, particularly if the drug proves effective in a new patient demographic. This could also impact competitors in the pharmaceutical industry focusing on similar treatments.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.