A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.
The purpose of this study was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 g/dL (range 11-13- g/dL).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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.
- The secondary objective was to evaluate safety in subjects with chronic kidney disease throughout the study
|Study Start Date:||June 2003|
|Study Completion Date:||September 2003|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495365
|Study Director:||Ortho Biotech Products, L.P. Clinical Trial||Ortho Biotech Products, L.P.|