An Open-Label, Randomized, Multi-center, Controlled Study of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease in the Long Term Care Setting

PROCRIT (Epoetin alfa) is a brand of recombinant human erythropoietin (rHuEPO). Erythropoietin is a hormone produced in the kidney. Its function is to stimulate the production of red blood cells in the bone marrow. Many patients with Chronic Kidney Disease (CKD) do not produce enough erythropoietin and thus develop anemia (a reduction in red blood cell levels). This can cause them to feel tired.

PROCRIT (Epoetin alfa) is approved by the United States Food and Drug Administration (FDA) for the treatment of anemia (low red blood cell count) in patients with CKD (not on dialysis). The approved dosing frequency for PROCRIT (Epoetin alfa) in patients with CKD is one injection three times per week. Although PROCRIT (Epoetin alfa) is approved by the FDA for the treatment of certain types of anemia at different dosing schedules, the dosing schedules that will be used in this study are investigational in CKD. An investigational use is one that is currently not approved by the FDA.

This is an open-label, randomized (patients are assigned different treatments based on chance), multi-center, controlled study of patients with anemia of Chronic Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. Approximately 156 patients with CKD, not on dialysis, who have not received an erythropoietin receptor agonist (a drug that stimulates red blood cell production) for eight weeks immediately prior to screening (Week -1) and who have a hemoglobin (Hb, a measure of the number of red blood cells), less than 11 g/dL at screening will be eligible to participate. Patients will be evaluated for eligibility during a one-week screening phase. Eligible patients will be randomized in a 3:1 ratio to a PROCRIT (Epoetin alfa) group or to the control group for a period of 26 weeks. Randomization is done through a computer that randomly assigns the subject by chance (like rolling dice) to one of two groups (No one can choose the group to which they will be assigned.). They will have a 3 to 1 chance of being assigned to Group 1 versus Group 2, which means that out of every 4 patients entering the study 3 will receive PROCRIT (Epoetin alfa) and 1 will not.

Group 1 -will receive PROCRIT (Epoetin alfa) 20,000 Units (U) every 2 weeks until the hemoglobin reaches 11.0 g/dL or higher and remains at this level for two measurements in a row. At Week 6 or thereafter, the 20,000 Unit dose may be adjusted upward or downward as required to obtain the two consecutive hemoglobin measurements. Once the two consecutive measurements have been achieved, PROCRIT (Epoetin alfa) will be given every 4 weeks (Q4W) at double the previous dose to obtain a target hemoglobin of up to 12.0 g/dL. There will be no conversion to Q4W before Week 6 or after Week 18. If the hemoglobin drops, patients may go back to receiving PROCRIT (Epoetin alfa) every 2-weeks. If the hemoglobin rises above 12.0 g/dL, patients will not receive another dose of PROCRIT (Epoetin alfa) until the Hg level is below 12.0 g/dL. If the hemoglobin rises rapidly, patients will not receive another dose of PROCRIT (Epoetin alfa) until the rise is 1 g/dL or less in a 2-week period. The maximum amount of PROCRIT (Epoetin alfa) that this group can receive is 60,000 Units over a 4-week period. All doses of PROCRIT (Epoetin alfa) are injected under the skin (subcutaneous).

Group 2 - will not receive any PROCRIT (Epoetin alfa). This group will continue to receive the care that they are now receiving from their physician and the physician will review all lab results.