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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

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