Status:
TERMINATED
Treatment of Anemia in Diabetic Subjects With CKD
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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/deci...
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 rati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00240734
Start Date
March 1 2005
End Date
September 1 2005
Last Update
June 10 2011
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