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| Sponsor: | Ortho Biotech Products, L.P. |
|---|---|
| Information provided by: | Ortho Biotech Products, L.P. |
| ClinicalTrials.gov Identifier: | NCT00495365 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Chronic Renal Insufficiency |
Drug: Epoetin alfa |
Phase IV |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 8 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00495365 History of Changes |
| Other Study ID Numbers: | CR005104 |
| Study First Received: | June 29, 2007 |
| Last Updated: | May 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Anemia low blood count chronic kidney disease chronic kidney failure |
darbepoetin alfa epoetin alfa recombinant human erythropoietin |
|
Anemia Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Renal Insufficiency Hematologic Diseases Urologic Diseases |
Darbepoetin alfa Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |