A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]; Drug: Epoetin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546481

ML20884

Details and patient eligibility

About

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic renal anemia;
• maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.

Exclusion criteria

• previous therapy with epoetin within 8 weeks prior to screening;
• overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
• RBC transfusions within 8 weeks before screening or during screening period;
• active malignant disease except non-melanoma skin cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Correction Phase: CERA

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]

Correction Phase: Epoetin Beta

Active Comparator group

Treatment:

Drug: Epoetin