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 assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of etelcalcetide in treating secondary hyperparathyroidism in pediatric patients with chronic kidney disease on hemodialysis. This research is significant as it targets a younger demographic that has been less studied in this context.
The intervention being tested is Etelcalcetide, a drug that has been effective in treating secondary hyperparathyroidism in adult patients with chronic kidney disease. The drug is administered intravenously three times a week, with doses adjusted based on patient response to maintain optimal levels of parathyroid hormone, calcium, and phosphorus.
This study is designed as an interventional, single-group assignment with no masking, meaning all participants receive the treatment, and both researchers and participants know what treatment is being administered. The primary purpose of the study is treatment-focused, aiming to evaluate the therapeutic effects of Etelcalcetide in the specified patient group.
The study began on December 20, 2019, with an estimated completion date in 2025. The last update was submitted on July 15, 2025. These dates are crucial for tracking the progress and expected outcomes of the study, providing investors with a timeline for potential market impacts.
The ongoing study could influence Amgen’s stock performance positively if results show significant benefits, as it would expand the use of Etelcalcetide to a new patient group. This could enhance investor sentiment and position Amgen favorably against competitors in the nephrology market.
The study is currently recruiting, with further details available on the ClinicalTrials portal.