Aranesp® Monthly Preference Study - 2

Amgen

Status and phase: Completed; Phase 4

Conditions: Kidney Disease

Treatments: Drug: Aranesp®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117078

20020380

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 8 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 Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Self-injecting at home with Procrit® - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)