Epoetin Alfa (EPO) in Subjects With Chronic Kidney Disease (CKD)
- Conditions
- Chronic Kidney Disease
- Interventions
- Drug: Epoetin alfa RBDrug: Epoetin alfa DT
- Registration Number
- NCT00156962
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to look at subject incidence of adverse events.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 850
- ≥ 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epoetin alfa RB Epoetin alfa RB - Epoetin alfa DT Epoetin alfa DT -
- Primary Outcome Measures
Name Time Method Subject incidence of adverse events Entire Study
- Secondary Outcome Measures
Name Time Method Epoetin alfa antibodies Entire Study Changes from baseline laboratory and vital signs Entire Study