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Sponsored by: |
Ortho Biotech Products, L.P. |
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Information provided by: | Ortho Biotech Products, L.P. |
ClinicalTrials.gov Identifier: | NCT00307814 |
The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as assessed by hemoglobin maintenance, adverse events and health-related quality of life.
Condition | Intervention | Phase |
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Chronic Renal Insufficiency Anemia |
Drug: Epoetin Alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Clinical Evaluation of PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease |
Estimated Enrollment: | 436 |
Study Start Date: | January 2002 |
Study Completion Date: | January 2004 |
Epoetin alfa has been widely utilized as treatment for anemia associated with Chronic Kidney Disease (CKD).
Epoetin alfa has been shown to increase hemoglobin (Hb) levels by an average of 1.5 g/dL to 2 g/dL in these patients over 12 weeks (Data on file Ortho Biotech Products, L.P.). This improvement in Hb levels is maintained while the patient is receiving Epoetin alfa and is associated with significant improvements in survival, exercise tolerance, and quality of life. Literature has suggested that epoetin alfa can be given less frequently and still maintain an optimal hemoglobin while also allowing patient's greater convenience. This study will further confirm that less frequent dosing of epoetin alfa is safe and effective. This is an open-label, randomized multicenter study in patients with CKD. CKD patients who are currently receiving PROCRIT therapy for at least 2 months or more and with a stable Hb (>= 11g/dL) will be randomized to one of four treatment groups. A stable Hemoglobin will be defined as a value that is ± 10% for 3 consecutive laboratory values. This study is designed to demonstrate that there is no meaningful difference in hemoglobin level with more extended dosing regimens as compared to once weekly. A clinically meaningful difference is defined as a difference that is less than 10%.
Patients will be randomized to one of 4 treatment groups: All will receive subcutaneous (under the skin) Epoetin alfa for a period of 16 weeks. Group 1: 10,000 units every week Group 2: 20,000 units every two weeks Group 3: 30,000 units every three weeks Group 4: 40,000 units every four weeks
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR005101 |
Study First Received: | March 24, 2006 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00307814 History of Changes |
Health Authority: | United States: Institutional Review Board |
recombinant human erythropoietin epoetin alfa Chronic Kidney Failure |
Chronic Kidney Disease Anemia Low Blood Count |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematinics Hematologic Diseases |
Renal Insufficiency, Chronic Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Epoetin Alfa Renal Insufficiency Hematologic Diseases Hematinics Hematologic Agents Anemia Kidney Failure, Chronic |
Pharmacologic Actions Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Kidney Diseases Kidney Failure |