Status:
COMPLETED
A Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Patients With Chronic Kidney Disease
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Chronic Kidney Disease
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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).
Detailed Description
This is a prospective, open-label (both the patient and the physician know the drug and drug dose being given), randomized (patients are assigned to a dosing regimen by chance), multicenter, pharmacok...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00641589
Start Date
January 1 2006
End Date
November 1 2006
Last Update
May 18 2011
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