A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.

• Status: Terminated
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• Subjects with chronic kidney disease defined as serum creatinine of 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 mg/dL for men

• glomerular filtration rate (GFR) within 15-60 mL/min

• Subjects on darbepoetin alfa for 3 months or more and with a stable entry hemoglobin level of 12 (plus or minus 1 g/dL

• range 11-13 g/dL)

• Subjects receiving darbepoetin alfa on an every two, three, or four week dosing schedule

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

Exclusion Criteria:

• No uncontrolled high blood pressure as assessed by the primary physician

• No known hypersensitivity to mammalian cell-derived products

• No known hypersensitivity to human albumin

• Not receiving dialysis or scheduled to receive dialysis during the course of the study

• No severe congestive heart failure (New York Heart Association Class IV)

• No known severe stable or unstable coronary artery disease.