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

Centocor Ortho Biotech

Status and phase

Terminated

Phase 4

Conditions

Anemia

Chronic Renal Insufficiency

Treatments

Drug: Epoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00495365

CR005104

Details and patient eligibility

About

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).

Full description

This was a prospective, multicenter study in subjects with chronic kidney disease. The study was designed to address hemoglobin stability after drug conversion to epoetin alfa in subjects previously receiving darbepoetin alfa therapy.

The study was to enroll approximately 180 subjects with chronic kidney disease. Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two, three, or four weeks for a period of 3 months or more and who had a stable hemoglobin (Hb) level at study entry of 12 g/dL (plus or minus 1 g/dL (11-13 g/dL). Subjects receiving darbepoetin alfa every 2, 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency ( every 2, 3 or 4 weeks) upon study entry and throughout the 24 week study period. Clinical safety was assessed for the occurrence and severity of adverse events. Blood tests (Complete Blood Count, platelets, reticulocyte count, iron, were assessed at pre-determined intervals throughout the study. Vital signs (e.g. Blood pressure) were checked at each visit. Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa. Subjects received 20,000 Units (U) epoetin alfa subcutaneously (SC) every two weeks; 30,000 U epoetin alfa SC every 3 weeks; or 40,000 U epoetin alfa SC every 4 weeks.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.