Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the hemoglobin response rate in subjects with anemia, associated with chronic kidney failure, after receiving epoetin alfa (PROCRIT®) every 2 weeks

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Subjects with chronic kidney disease and a glomerular filtration rate within 10-60 ml/min/1.73m2 with no expected need for dialysis during the study

• subjects with a hemoglobin less than 11 g/dL

• subjects who have not received erythropoietic agents within 6 weeks before study entry

• female subjects, with a reproductive potential, must have a negative urine pregnancy test within 7 days of the first dose of study drug.

Exclusion Criteria:

• Subjects with poorly controlled high blood pressure (hypertension) - systolic > 150 mm Hg or diastolic > 100 mm Hg

• known hypersensitivity to human albumin and/or mammalian cell-derived products

• subjects receiving dialysis

• subjects with a ferritin level < 50 ng/mL, Transferrin Saturation < 20%

• subjects receiving chemotherapy for cancer within 1 month prior to study start or expected during study participation

• Pregnancy or lactation.