Status:
COMPLETED
A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 hemog...
Detailed Description
Epoetin alfa has been widely utilized as treatment for anemia associated with Chronic Kidney Disease (CKD). Epoetin alfa has been shown to increase hemoglobin (Hb) levels by an average of 1.5 g/dL to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
519 Patients enrolled
Trial Details
Trial ID
NCT00307814
Start Date
January 1 2002
End Date
January 1 2004
Last Update
May 19 2011
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