Status:
COMPLETED
Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00210743
Start Date
May 1 2004
End Date
October 1 2005
Last Update
May 23 2011
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