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

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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