- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00495365
A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.
Evaluation of Dose Conversion From Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa in Patients With the Anemia of Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a prospective, multicenter study in subjects with chronic kidney disease. The study was designed to address hemoglobin stability after drug conversion to epoetin alfa in subjects previously receiving darbepoetin alfa therapy.
The study was to enroll approximately 180 subjects with chronic kidney disease. Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two, three, or four weeks for a period of 3 months or more and who had a stable hemoglobin (Hb) level at study entry of 12 g/dL (plus or minus 1 g/dL (11-13 g/dL). Subjects receiving darbepoetin alfa every 2, 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency ( every 2, 3 or 4 weeks) upon study entry and throughout the 24 week study period. Clinical safety was assessed for the occurrence and severity of adverse events. Blood tests (Complete Blood Count, platelets, reticulocyte count, iron, were assessed at pre-determined intervals throughout the study. Vital signs (e.g. Blood pressure) were checked at each visit. Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa. Subjects received 20,000 Units (U) epoetin alfa subcutaneously (SC) every two weeks; 30,000 U epoetin alfa SC every 3 weeks; or 40,000 U epoetin alfa SC every 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with chronic kidney disease defined as serum creatinine of 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 mg/dL for men
- glomerular filtration rate (GFR) within 15-60 mL/min
- Subjects on darbepoetin alfa for 3 months or more and with a stable entry hemoglobin level of 12 (plus or minus 1 g/dL
- range 11-13 g/dL)
- Subjects receiving darbepoetin alfa on an every two, three, or four week dosing schedule
- female subjects with a reproductive potential must have a negative ruine pregnancy test within 7days of the first dose of study drug.
Exclusion Criteria:
- No uncontrolled high blood pressure as assessed by the primary physician
- No known hypersensitivity to mammalian cell-derived products
- No known hypersensitivity to human albumin
- Not receiving dialysis or scheduled to receive dialysis during the course of the study
- No severe congestive heart failure (New York Heart Association Class IV)
- No known severe stable or unstable coronary artery disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary objective was to evaluate the proportion of subjects who maintained hemoglobin levels within 10% of entry levels and/or a range of 11-13 g/dL for the 24-week duration of the study.
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Secondary Outcome Measures
Outcome Measure |
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The secondary objective was to evaluate safety in subjects with chronic kidney disease throughout the study
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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