Subject incidence of adverse events.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: Epoetin alfa	Phase III

Further Study Details: 

Primary Outcomes: Subject incidence of adverse events
Secondary Outcomes: Epoetin alfa antibodies. Changes from baseline laboratory and vital signs
Expected Total Enrollment:  850

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• ≥ 18 years of age
• CKD not on dialysis: estimated GFR of 15mL/min to 60 mL/min (MDRD equation)
• Clinically stable
• Mean of all screening/baseline 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 > 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 (iPTH >1500 pg/ml or 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00156962

Amgen Call Center      866-572-6436 

Alabama
      Research Site, Birmingham,  Alabama,  United States; Recruiting
      Research Site, Montgomery,  Alabama,  United States; Recruiting
Arizona
      Research Site, Phoenix,  Arizona,  United States; Recruiting
      Research Site, Tempe,  Arizona,  United States; Recruiting
California
      Research Site, Bakersfield,  California,  United States; Recruiting
      Research Site, Cudahy,  California,  United States; Recruiting
      Research Site, Fountain Valley,  California,  United States; Recruiting
      Research Site, Granada Hills,  California,  United States; Recruiting
      Research Site, Huntington Beach,  California,  United States; Recruiting
      Research Site, La Jolla,  California,  United States; Recruiting
      Research Site, Long Beach,  California,  United States; Recruiting
      Research Site, Los Angeles,  California,  United States; Recruiting
      Research Site, Orange,  California,  United States; Recruiting
      Research Site, San Diego,  California,  United States; Recruiting
      Research Site, Stanford,  California,  United States; Recruiting
Colorado
      Research Site, Denver,  Colorado,  United States; Recruiting
      Research Site, Thornton,  Colorado,  United States; Recruiting
District of Columbia
      Research Site, Washington,  District of Columbia,  United States; Recruiting
Florida
      Research Site, Brandon,  Florida,  United States; Recruiting
      Research Site, Deerfield Beach,  Florida,  United States; Recruiting
      Research Site, Lauderdale Lakes,  Florida,  United States; Recruiting
      Research Site, Miami,  Florida,  United States; Recruiting
      Research Site, New Port Richey,  Florida,  United States; Recruiting
      Research Site, Ocala,  Florida,  United States; Recruiting
      Research Site, Pinecrest,  Florida,  United States; Recruiting
      Research Site, Tampa,  Florida,  United States; Recruiting
      Research Site, Winterhaven,  Florida,  United States; Recruiting
Georgia
      Research Site, Atlanta,  Georgia,  United States; Recruiting
      Research Site, Columbia,  Georgia,  United States; Recruiting
      Research Site, Columbus,  Georgia,  United States; Recruiting
Illinois
      Research Site, Chicago,  Illinois,  United States; Recruiting
      Research Site, Evanston,  Illinois,  United States; Recruiting
      Research Site, North Chicago,  Illinois,  United States; Recruiting
      Research Site, Oak Brook,  Illinois,  United States; Recruiting
      Research Site, Park Ridge,  Illinois,  United States; Recruiting
Indiana
      Research Site, Fort Wayne,  Indiana,  United States; Recruiting
      Research Site, Indianapolis,  Indiana,  United States; Recruiting
      Research Site, Valparaiso,  Indiana,  United States; Recruiting
Kansas
      Research Site, Kansas City,  Kansas,  United States; Recruiting
      Research Site, Mission,  Kansas,  United States; Recruiting
      Research Site, Overland Park,  Kansas,  United States; Recruiting
Maryland
      Research Site, Baltimore,  Maryland,  United States; Recruiting
      Research Site, Bethesda,  Maryland,  United States; Recruiting
Massachusetts
      Research Site, Boston,  Massachusetts,  United States; Recruiting
      Research Site, Springfield,  Massachusetts,  United States; Recruiting
      Research Site, Worcester,  Massachusetts,  United States; Recruiting
Michigan
      Research Site, Detroit,  Michigan,  United States; Recruiting
      Research Site, Livonia,  Michigan,  United States; Recruiting
Missouri
      Research Site, St. Louis,  Missouri,  United States; Recruiting
New Jersey
      Research Site, Newark,  New Jersey,  United States; Recruiting
New York
      Research Site, Binghamton,  New York,  United States; Recruiting
      Research Site, Johnson City,  New York,  United States; Recruiting
      Research Site, New York,  New York,  United States; Recruiting
      Research Site, Rochester,  New York,  United States; Recruiting
North Carolina
      Research Site, Cary,  North Carolina,  United States; Recruiting
      Research Site, Fayetteville,  North Carolina,  United States; Recruiting
      Research Site, Greenville,  North Carolina,  United States; Recruiting
Ohio
      Research Site, Cincinnati,  Ohio,  United States; Recruiting
      Research Site, Columbus,  Ohio,  United States; Recruiting
      Research Site, Dayton,  Ohio,  United States; Recruiting
Oregon
      Research Site, Bend,  Oregon,  United States; Recruiting
      Research Site, Roseburg,  Oregon,  United States; Recruiting
Pennsylvania
      Research Site, Allentown,  Pennsylvania,  United States; Recruiting
      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting
Rhode Island
      Research Site, Providence,  Rhode Island,  United States; Recruiting
South Carolina
      Research Site, Hampton,  South Carolina,  United States; Recruiting
      Research Site, Orangeburg,  South Carolina,  United States; Recruiting
Tennessee
      Research Site, Chattanooga,  Tennessee,  United States; Recruiting
      Research Site, Jackson,  Tennessee,  United States; Recruiting
      Research Site, Jefferson City,  Tennessee,  United States; Recruiting
      Research Site, Knoxville,  Tennessee,  United States; Recruiting
      Research Site, Memphis,  Tennessee,  United States; Recruiting
      Research Site, Morristown,  Tennessee,  United States; Recruiting
Texas
      Research Site, Corpus Christi,  Texas,  United States; Recruiting
      Research Site, Houston,  Texas,  United States; Recruiting
      Research Site, Lubbock,  Texas,  United States; Recruiting
      Research Site, San Antonio,  Texas,  United States; Recruiting
Vermont
      Research Site, Burlington,  Vermont,  United States; Recruiting
Virginia
      Research Site, Arlington,  Virginia,  United States; Recruiting
      Research Site, Hampton,  Virginia,  United States; Recruiting
      Research Site, Norfolk,  Virginia,  United States; Recruiting
West Virginia
      Research Site, Morgantown,  West Virginia,  United States; Recruiting
Wisconsin
      Research Site, Milwaukee,  Wisconsin,  United States; Recruiting
Puerto Rico
      Research Site, Caguas,  Puerto Rico; Recruiting
      Research Site, Ponce,  Puerto Rico; Recruiting
      Research Site, Rio Piedras,  Puerto Rico; Recruiting
      Research Site, San Juan,  Puerto Rico; Recruiting

Study ID Numbers:  20040259
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156962
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13