Clinical trial NCT00440466
Conditions: Anemia Renal Diseases
Keywords: Anemia Reduction in the number of erythrocytes Hemoglobin low level Red blood cell deficiency Procrit Epoetin alfa Chronic kidney disease
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2007-07-01; Completion date: 2009-03-01
Enrollment: 430 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Detailed description:
A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

Arms: arm 1: epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks arm 2: epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk arm 3: epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Interventions: intervention 1: epoetin alfa intervention 2: epoetin alfa intervention 3: epoetin alfa
Intervention descriptions: intervention 1: Continue pre-study once weekly dose of epoetin alfa for 36 weeks intervention 2: Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks intervention 3: Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Protocol documents: