Study Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney Disease
Tracking Information
Start Date ICMJE | June 2009 |
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Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: June 18, 2009) | Hb change between baseline and the evaluation period (weeks 29-33) [ Time Frame: Baseline to Week 33 (end of study) ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00925587 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: June 18, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney Disease |
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Official Title ICMJE | A Multicenter, Randomised, Double-Blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis |
Brief Summary | The purpose of this study is to determine whether taking darbepoetin alfa once monthly is as safe and effective in raising red blood cell levels as taking darbepoetin alfa once every 2 weeks. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE | Drug: darbepoetin alfa Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg. Other Name: Placebo |
Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 540 | ||||
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Estimated Completion Date | September 2011 | ||||
Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Australia, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Poland, Portugal, Russian Federation, Spain, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00925587 | ||||
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Responsible Party | Global Development Leader, Amgen Inc. | ||||
Study ID Numbers ICMJE | 20060163 | ||||
Study Sponsor ICMJE | Amgen | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Amgen |
Source: http://clinicaltrials.gov/