Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
A Multicenter, Single Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing In Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who have achieved and maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and their caregivers.
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 Mar 2004
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, 2004
CompletedFirst Submitted
Initial submission to the registry
May 17, 2005
CompletedFirst Posted
Study publicly available on registry
May 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedAugust 8, 2008
August 1, 2008
1.7 years
May 17, 2005
August 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL during the evaluation phase
Entire Study
Secondary Outcomes (3)
To determine Hb values over the duration of the study
Entire Study
To determine darbepoetin alfa doses over the duration of the study
Entire Study
To assess the safety of darbepoetin alfa
Entire Study
Study Arms (1)
darbepoetin alfa
EXPERIMENTALInterventions
QM administration for 28 weeks, adjusted as necessary to maintain Hb between 11.0 - 13.0 g/dL PFS concentrations: 20, 30, 40, 50, 60, 80, 100, 150, 200 and 300 mcg.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (2)
Agarwal AK, Silver MR, Reed JE, Dhingra RK, Liu W, Varma N, Stehman-Breen C. An open-label study of darbepoetin alfa administered once monthly for the maintenance of haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis. J Intern Med. 2006 Dec;260(6):577-85. doi: 10.1111/j.1365-2796.2006.01723.x.
PMID: 17116009RESULTSilver MR, Agarwal A, Krause M, Lei L, Stehman-Breen C. Effect of darbepoetin alfa administered once monthly on maintaining hemoglobin levels in older patients with chronic kidney disease. Am J Geriatr Pharmacother. 2008 Jun;6(2):49-60. doi: 10.1016/j.amjopharm.2008.05.002.
PMID: 18675764RESULT
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
May 17, 2005
First Posted
May 18, 2005
Study Start
March 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
August 8, 2008
Record last verified: 2008-08