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Study Complete
Sponsor ID
20020147

Study to Evaluate Effectiveness of Aranesp®

Sponsor ID
20020147
Clinicaltrials.gov ID
NCT00117130
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 4
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Nov 2002 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 12 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/1.73 m2 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20%
    Exclusion Criteria:
    - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy