Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease
Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
1 other identifier
interventional
446
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with chronic kidney disease (CKD) receiving hemodialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
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
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 18, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFebruary 28, 2008
February 1, 2008
7 months
July 18, 2005
February 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Hb level between the screening/baseline period and the evaluation period
30 weeks
The ratio of weekly dosing requirements between baseline and the evaluation period
28 weeks
Secondary Outcomes (4)
Change from baseline Hb over time
29 weeks
Proportion of subjects maintaining mean Hb within target range during evaluation period
7 weeks
Average darbepoetin alfa dose over evaluation period
7 weeks
Change from baseline dose over time
29 weeks
Study Arms (2)
Roller bottle
ACTIVE COMPARATORSerum free
EXPERIMENTALInterventions
Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment. Frequency either once a week or once every two weeks, frequency may not change for duration of study. Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study. Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVED
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 18, 2005
First Posted
July 21, 2005
Study Start
March 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2006
Last Updated
February 28, 2008
Record last verified: 2008-02