A Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Patients With Chronic Kidney Disease

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to describe how four different dosing regimens of PROCRIT (epoetin alfa) are utilized in patients with anemia due to non-dialysis chronic kidney disease (CKD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Centocor Ortho Biotech Services, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients with a Glomerular Filtration Rate (GFR) within 15-60 mL/min/1.73m2 and stable creatinine over the past 6 months and no expected need for dialysis during the study

• Patients with a hemoglobin (Hg) < 11 g/dL at Screening

• Patients with a transferrin saturation >= 20% or a ferritin >= 50 ng/mL.

• Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose

• Patients with reproductive potential must have a negative B-HCG pregnancy test within 14 days of the first dose of study drug and a negative urine pregnancy test on the day of the first dose of study drug

• Patients and their partners must be practicing an effective method of birth control before entry and throughout the study

Exclusion Criteria:

• Exclusion criteria include but are not limited to the following: Patients with significant hematological disease (disorders of the blood and blood forming tissues

• including but not limited to myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy)

• Patients with liver function test results > 2 or more times the normal value

• Patients with new onset seizures (within the last 3 months) or seizures not controlled by medication prior to admission in to the study

• Patients with a history of thrombotic vascular events (including by not limited to acute myocardial infarction (AMI) within the previous 6 months, stroke, transient ischemic attack (TIA), deep vein thrombosis,(DT) and pulmonary embolism (PE)

• Patients with poorly controlled or uncontrolled hypertension

• Patients with anemia due to blood loss.