Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
- Registration Number
- NCT00436995
- Lead Sponsor
- Amgen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Darbepoetin Alfa -
- Primary Outcome Measures
Name Time Method Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period. 33 weeks
- Secondary Outcome Measures
Name Time Method Q2W doses over duration of study. 33 weeks Hb values during the evaluation period. 33 weeks adverse events during study 33 weeks Hb Rate of Rise during study and excursions above 14g/dL 33 weeks