Status:
TERMINATED
A Study to Assess Disability in Anemic Elderly Patients With Kidney Disease Receiving PROCRIT (Epoetin Alfa)
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Kidney Diseases
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess disability in anemic patients over the age of 65 who have kidney disease and are receiving weekly PROCRIT® (Epoetin Alfa, a glycoprotein that stimulates red blo...
Detailed Description
This is an open-label study in which PROCRIT® (Epoetin Alfa) will be given on a weekly basis starting at a dose lower than is currently approved by the U.S. FDA because treatment is beginning at a hig...
Eligibility Criteria
Inclusion
- Patients having chronic anemia and chronic renal failure
- have lessened physical function
- be community dwelling (defined as not admitted to an assisted nursing facility, nursing home or hospital at the time of enrollment. An assisted nursing facility is considered any living situation where daily care is being provided by recognized health care professionals from that facility.)
Exclusion
- History of bacterial infection requiring hospitalization and intravenous antibiotics or transfusion within 1 month prior to enrollment
- anemia due to iron, folate, or vitamin B12 deficiency
- gastrointestinal bleeding
- anticipated to begin dialysis within 4 months following enrollment into the study
- History of thrombotic disease within the past 3 months, or on anticoagulation therapy at enrollment.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00338468
Start Date
November 1 2003
End Date
September 1 2005
Last Update
May 19 2011
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