Overview
A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)
Status:
Completed
Completed
Trial end date:
2004-01-01
2004-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as assessed by hemoglobin maintenance, adverse events and health-related quality of life.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ortho Biotech Products, L.P.Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:- CKD patients (defined as serum creatinine 1.5 to 6.0 mg/dL for women and 2.0 to 6.0
g/mg/dL for men)
- Stable Hb (>= 11.0g/dL) and currently receiving PROCRIT therapy for 2 months or more.
A stable Hemoglobin will be defined as a value that is ± 10% for 3 consecutive
laboratory values.
Exclusion Criteria:
- Lactating or pregnant women
- Uncontrolled hypertension
- Known hypersensitivity to mammalian cell-derived products and human albumin
- Receiving dialysis or scheduled to receive dialysis during the course of the study
- gastrointestinal bleeding
- Severe Congestive Heart Failure (New York Heart Association Class IV)
- Concurrent chemotherapy for cancer
- History of/or active blood disorders, liver diseases or seizures
- HIV positive
- Received a kidney transplant