Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
1 other identifier
interventional
114
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2006
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 21, 2011
January 1, 2011
9 months
February 15, 2007
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
33 weeks
Secondary Outcomes (4)
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
Study Arms (1)
Single
OTHERInterventions
Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 15, 2007
First Posted
February 19, 2007
Study Start
April 1, 2006
Primary Completion
January 1, 2007
Study Completion
December 1, 2008
Last Updated
January 21, 2011
Record last verified: 2011-01