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.
Condition: Renal Failure , Chronic; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia
Intervention: Epoetin Alfa; Standard of care
Intervention description: Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Long Term Care Facilities; subcutaneous injections; PROCRIT; Epoetin alfa; Anemia

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 maintain Hb levels, is safe and effective in patients with anemia from Chronic
      Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study
      the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.