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An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis

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Trial Profile

An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Methoxy polyethylene glycol-epoetin beta (Primary)
  • Indications Anaemia
  • Focus Therapeutic Use
  • Acronyms DOLPHIN
  • Sponsors Roche

    • Most Recent Events

    • 26 Nov 2019 Results of analysis of five clinical studies: BA1620 (n=133), BA16528 (n=65), AMICUS (n=135), MAXIMA (n=122), PROTOS (n=143) and DOLPHIN (n=63) assessing optimisation of the C.E.R.A. development programme in paediatric patients with anaemia of Chronic kidney disease were published in the British Journal of Clinical Pharmacology
    • 15 Jun 2018 New trial record
    • 07 Jun 2018 Based on the data from this trial the Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.
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