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
Price :
$35
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At a glance
- Drugs Methoxy polyethylene glycol-epoetin beta (Primary)
- Indications Anaemia
- Focus Therapeutic Use
- Acronyms DOLPHIN
- Sponsors Roche
- 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.