Overview

A Study to Assess Disability in Anemic Elderly Patients With Kidney Disease Receiving PROCRIT (Epoetin Alfa)

Status:
Terminated
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
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 blood cell production).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ortho Biotech Products, L.P.
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.