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Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to lesser than 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Trial Profile

Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to lesser than 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2023

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At a glance

  • Drugs Etelcalcetide (Primary)
  • Indications Renal failure; Secondary hyperparathyroidism
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen
  • Most Recent Events

    • 08 Dec 2022 Planned End Date changed from 29 Jun 2026 to 30 Jan 2026.
    • 13 Jul 2022 Planned End Date changed from 31 Jan 2023 to 29 Jun 2026.
    • 13 Jul 2022 Planned primary completion date changed from 31 Jan 2023 to 30 Jan 2026.
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