Aranesp® Monthly Preference Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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Conditions

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Kidney Disease

Keywords

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Kidney disease, Renal, CKD (Chronic Kidney Disease) CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen Aranesp®, Darbepoetin alfa, QW dosing Q2W dosing, Q4W dosing Patient preference, Subject preference

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aranesp®

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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United States

Other Identifiers

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20020380

Identifier Type: -

Identifier Source: org_study_id

Aranesp® Monthly Preference Study - 2