Status:
COMPLETED
Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
Lead Sponsor:
Amgen
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00436995
Start Date
April 1 2006
End Date
December 1 2008
Last Update
January 21 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.