Anemia
Conditions
Keywords
Anemia, Chronic renal failure, pre-dialysis, diabetic
Brief summary
The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRIT®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline by Week 17.
Detailed description
This is a prospective, randomized, double blind, placebo controlled, multi-center study in diabetic subjects with the anemia of chronic kidney disease. Subjects will be randomly assigned in a 1:1 ratio to receive either Epoetin alfa (PROCRIT®) or matching placebo for sixteen weeks. Epoetin alfa (PROCRIT®) is indicated for the treatment of anemia associated with chronic renal failure (pre-dialysis), non-myeloid malignancies receiving chemotherapy, in HIV-infected subjects receiving zidovudine therapy, and in anemic subjects undergoing elective non-cardiac, non-vascular surgery to reduce the need for allogenic blood transfusion during high-volume blood loss procedures. This study is being undertaken to assess, under well-controlled conditions, the effect of weekly Epoetin alfa (PROCRIT®) treatment on hemoglobin response in diabetic subjects with the anemia of chronic kidney disease. The study hypothesis is that weekly PROCRIT treatment will be effective in achieving a hemoglobin response than placebo, where hemoglobin response is defined by at least a 1 gram/deciliter increase from baseline by Week 17. The subjects are administered study drug (PROCRIT® or matching placebo) once weekly by subcutaneous injection by a health care professional for 16 weeks. The initial dose of study drug is either PROCRIT® 10,000 U (1.0 mL) or matching placebo. The maximum dose administered is 20,000 U (2.0 mL).
Interventions
DRUGEpoetin alfa
Sponsors
Ortho Biotech Products, L.P.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with a clinical diagnosis of diabetes mellitus * History of documented proteinuria or microalbuminuria * A glomerular filtration rate between 15 and 90 mL/minute/1.73m2 * Subjects with hemoglobin greater than or equal to 9.0 /dL and less than or equal to 11.0 g/dL.
Exclusion criteria
* A current diagnosis of poorly controlled high blood pressure (hypertension) (systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 100 mm Hg) after adequate anti hypertensive therapy * Subjects with severe neuropathy or peripheral vascular disease with gait instability * Subjects scheduled to receive dialysis during the course of the study * Subjects with a transferrin saturation \< 20% or ferritin level \< 50 ng/dL * Subjects with active malignancy, defined as a malignancy requiring current therapy (surgery, chemotherapy, or radiotherapy) or a history of treatment for malignancy in the last 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the hemoglobin response rate, defined as the proportion of subjects who achieve at least a 1 gram per deciliter hemoglobin increase from baseline by Week 17. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include evaluation of health-related quality life, hemoglobin change over time, time to hemoglobin response, and transfusion utilization. | — |
Outcome results
None listed