A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394953

BH17847

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic renal anemia;
• hemodialysis 3 times weekly for >=12 weeks before screening, and during screening/baseline period;
• receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion criteria

• overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
• transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
• active malignancy;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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490 participants in 2 patient groups

MIRCERA

Experimental group

Description:

Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Darbepoetin Alfa

Active Comparator group

Description:

Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.

Treatment:

Drug: Darbepoetin alfa