An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin Alfa in Paediatric Subjects From Birth to Less Than 1 Year of Age With Anemia Due to Chronic Kidney Disease

Trial Profile

An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin Alfa in Paediatric Subjects From Birth to Less Than 1 Year of Age With Anemia Due to Chronic Kidney Disease

Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 20 Jun 2016

At a glance

  • Drugs Darbepoetin alfa (Primary)
  • Indications Anaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Amgen
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 16 Jun 2016 Status changed from not yet recruiting to withdrawn prior to enrolment due to Difficulty in recruitment.
    • 27 Apr 2016 Planned initiation date changed from 1 Apr 2016 to 1 May 2016.
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