NCT00717366

Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis

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: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV 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.

Conditions

• Renal Anemia

Interventions

Type	Name	Description
DRUG	Methoxy Polyethylene Glycol-Epoetin Beta	Will be administered IV, every 4 weeks.

Timeline

• Start date: 2008-07-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2008-07-17
• Last updated: 2017-09-08
• Results posted: 2017-09-08

Locations

39 sites across 12 countries: Australia, Belgium, France, Germany, Hungary, Italy, Poland, Romania, Russia, Spain, Thailand, Ukraine