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

NCT00717366

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Renal Anemia

Interventions: Methoxy Polyethylene Glycol-Epoetin Beta

Countries: Australia, Belgium, France, Germany, Hungary, Italy, Poland, Romania

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.

Eligibility overview

Sex: ALL

Age: 5 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia
* Hemodialysis for greater than or equal to (\>=) 8 weeks
* Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for \>= 8 weeks before screening and with no weekly dose change \>= 25 percent (%) (increase or decrease) during the 2 weeks of screening

Exclusion Criteria:

* Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
* Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period
* Active malignant disease
* Pure red cell aplasia (PRCA) or history of PRCA
* Pregnant or lactating females
* Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment

Locations (39)

Parkville, Victoria, Australia
Brussels, Belgium
Leuven, Belgium
Bron, France
Lille, France
Marseille, France
Montpellier, France
Paris, France
Paris, France
Strasbourg, France
Cologne, Germany
Hamburg, Germany
Heidelberg, Germany
Memmingen, Germany
Münster, Germany
Budapest, Hungary
Rome, Lazio, Italy
Genoa, Liguria, Italy
Turin, Piedmont, Italy
Padova, Veneto, Italy
Gdansk, Poland
Lodz, Poland
Lublin, Poland
Szczecin, Poland
Torun, Poland
Warsaw, Poland
Wroclaw, Poland
Bucharest, Romania
Iași, Romania
Moscow, Russia
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