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

Roche

Status and phase: Completed; Phase 2

Conditions: Renal Anemia

Treatments: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717366

2007-007758-70 (EudraCT Number)

NH19707

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

MIRCERA Group 1: Intermediate-Conversion-Factor Group

Experimental group

Description:

Participants will receive methoxy polyethylene glycol-epoetin beta (MIRCERA) IV injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-stimulating Agent (ESA) dose (4 \* previous weekly epoetin dose \[international units {IU}\]/250 or 4 \* previous weekly darbepoetin alfa dose \[micrograms {mcg}\]/1.1) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.

Treatment:

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

MIRCERA Group 2: High-Conversion-Factor Group

Experimental group

Description:

Participants will receive MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/125 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/0.55) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with Hb within ± 1 g/dL of their baseline Hb and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.

Treatment:

Drug: Methoxy Polyethylene Glycol-Epoetin Beta