Status:
COMPLETED
A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Renal Failure , Chronic
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks (Q4W) to ma...
Detailed Description
PROCRIT (Epoetin alfa) is a brand of recombinant human erythropoietin (rHuEPO). Erythropoietin is a hormone produced in the kidney. Its function is to stimulate the production of red blood cells in th...
Eligibility Criteria
Inclusion
- Chronic Kidney Disease (CKD) Stage 3, 4, or 5 (not on dialysis), Glomerular Filtration Rate (GFR) \[\<60 mL/min/1.73 m2\], or CKD Stage 2 (GFR 61-90 mL/min/1.73 mm2) with evidence of kidney damage (defined as structural or functional abnormalities of the kidneys) for greater than 3 months
- Hb \<11 g/dL measured at screening and a stable creatinine over the last 3 months
- expected to stay in a Long Term Care (LTC) facility for at least six months
- not receiving erythropoietic agents within eight weeks prior to screening.
Exclusion
- No significant hematological disease (including, but not limited to, myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy), or with a current diagnosis of anemia due to blood loss (e.g., hemolysis or gastrointestinal bleeding) or any cause of anemia other than CKD (e.g., hypothyroidism, HIV)
- No history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months prior to screening (prior superficial thrombophlebitis is not an exclusion criterion), or a history of cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute Coronary Syndrome (ACS), or other arterial thrombosis within 6 months before study entry. \[ACS includes Unstable Angina, Q wave Myocardial Infarction and non-Q wave Myocardial Infarction\]
- No uncontrolled or severe cardiovascular disease including uncontrolled hypertension (systolic BP \> 170 mm/Hg, or diastolic BP \> 100 mm/Hg), or congestive heart failure (New York Heart Association (NYHA) Class IV)
- No known solid tumor malignancy, receiving chemotherapy for cancer or having major surgery within one month prior to screening or expected during study participation
- No history of receiving a transplanted organ, or scheduled to receive an organ transplant during the course of the study, with the exception of a corneal transplant.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00337935
Start Date
July 1 2006
End Date
July 1 2009
Last Update
May 13 2013
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