Study to Evaluate Effectiveness of Aranesp®

Amgen

Overview

The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Kidney Disease

Interventions

Aranesp®DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20% Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

Outcomes

Primary Outcomes

Subject preference

Secondary Outcomes

Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion.

Data from ClinicalTrials.gov

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