Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

Amgen

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Darbepoetin Alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436995

20050210

Details and patient eligibility

About

The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receiving dialysis for 3 months or more before enrollment.
• The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
• Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
• Adequate iron stores (serum ferritin equal to or greater than 100 ug/L

Exclusion criteria

• Uncontrolled hypertension
• Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
• Other hematological disorders
• Upper or lower GI bleed within the prior 6 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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114 participants in 1 patient group

Single

Other group

Treatment:

Drug: Darbepoetin Alfa