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A Study of Intravenous Mircera for the Treatment of Anemia in Pediatric Patients on Hemodialysis

Anemia Clinical Trial

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

Clinical Trial Summary

This sequential study will assess the efficacy and safety of multiple doses of intravenous Mircera, and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric patients will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive intravenous Mircera monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00717366
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 2
Start date July 2008
Completion date March 2016
View Details
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