A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• 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