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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Anemia; Kidney Diseases

Treatments: Drug: epoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00210743

CR004600

Details and patient eligibility

About

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

Full description

This is a prospective study in non-dialysis subjects with anemia associated with chronic kidney disease. Subjects will be enrolled from multiple centers in the United States. The primary objective of the study is to evaluate hemoglobin response rate. The secondary objectives include evaluating the time to when hemoglobin responds, indicated by the results of the hemoglobin blood levels, the change in hemoglobin over time, the transfusion requirements and change in quality of life measurements. These measurements asks for the subjects views about how one feels, activity and energy level, etc. The subjects are administered study drug every 2 weeks through Study Week 27 unless dosing is held or the subject withdraws from the study. Each injection of study drug should not exceed 1 ml in volume.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)