A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: epoetin beta [NeoRecormon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321919

BA16169

Details and patient eligibility

About

This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

Enrollment: 605 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• chronic renal anemia;
• not receiving renal replacement therapy.

Exclusion criteria

• women who are pregnant or lactating;
• previous treatment with erythropoietin or other erythropoietic substance;
• blood transfusion within the last 3 months;
• need for dialysis expected in the next 6 months;
• administration of another investigational drug within 30 days preceding study start, or during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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605 participants in 2 patient groups

Early Epoetin Beta Therapy

Experimental group

Description:

Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.

Treatment:

Drug: epoetin beta [NeoRecormon]

Drug: epoetin beta [NeoRecormon]

Late Epoetin Beta Therapy

Active Comparator group

Description:

Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to \<10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.

Treatment:

Drug: epoetin beta [NeoRecormon]

Drug: epoetin beta [NeoRecormon]