Back to Search Results
Study Complete
Sponsor ID
20050210

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

Sponsor ID
20050210
Clinicaltrials.gov ID
NCT00436995
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
114
Additional Study Details

Protocol Summary

Primary Outcome Measures

Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.

Timeframe: 33 weeks

Secondary Outcome Measures

Q2W doses over duration of study.

Timeframe: 33 weeks

Hb values during the evaluation period.

Timeframe: 33 weeks

adverse events during study

Timeframe: 33 weeks

Hb Rate of Rise during study and excursions above 14g/dL

Timeframe: 33 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Apr 2006 - Jan 2007
    Inclusion and Exclusion 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