epoetin alfa (epo) in subjects with chronic kidney disease (ckd)

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to look at subject incidence of adverse events.

to determine whether epoetin alfa manufactured by a roller bottle technology (epoetin alfa rb) and epoetin alfa manufactured by a deep tank process (epoetin alfa dt) have a comparable safety profile when administered to patients with ckd not on dialysis.

Eligibility criteria:
inclusion criteria: - ≥ 18 years of age - ckd not on dialysis: estimated glomerular filtration rate (gfr) of 15ml/min to 60 ml/min (modification of diet in renal disease \[mdrd\] equation) - clinically stable - mean of all screening/baseline hemoglobin (hb) values between 11.0 to 13.0 g/dl - currently receiving epoetin alfa rb (ie. epogen or procrit) at the same dosing frequency for at least four weeks prior to randomization with no more than 1 missed or withheld dose in each of the 2 week periods - adequate iron stores (transferrin saturation \> 15.0%) - no prior use of erythropoietic agents other than epogen, procrit or aranesp exclusion criteria: - currently receiving treatment with any erythropoietic stimulating protein other than epogen or procrit. - prior use of erythropoietic agents other than epogen, procrit or aranesp. - uncontrolled hypertension (defined as diastolic blood pressure \[bp\] \> 110 mmhg or systolic bp \> 180 mmhg during screening). - grand mal seizure within the last 6 months prior to screening. - acute myocardial ischemia; hospitalization for congestive heart failure or myocardial infarction within 12 weeks before randomization. - stroke (hemorrhagic or ischemic) or transient ischemic attack within 12 weeks before randomization. - major surgery within 3 months prior to screening (excluding vascular access surgery). - clinical evidence of systemic infection or inflammatory disease at the time of screening and up until randomization. - known history of severe hyperparathyroidism (intact parathyroid hormone \[ipth\] \>1500 pg/ml or bio-intact parathyroid hormone \[bipth\] \> 800 pg/ml within 3 months prior to randomization). - known positivity for hiv antibody or hepatitis b surface antigen. - clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin. - blood transfusions within 8 weeks prior to screening or active bleeding. - androgen therapy within 8 weeks prior to screening. - interferon therapy. patients known to have tested positive at any time in the past for antibodies to erythropoietic proteins. - systemic hematological disease (eg. sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia. - other investigational products are excluded. - subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s). - psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study. - pregnant or breast feeding (women of child-bearing potential must be taking adequate contraceptive precautions). - anticipating or scheduled for a living-related kidney transplant. - currently receiving home hemodialysis treatment. - currently receiving immunosuppressive therapy.

Keywords: epogen procrit chronic kidney disease anemia treatment