Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.
Brief Summary: This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.


Options:
A: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* not receiving renal replacement therapy.

Exclusion Criteria:

* women who are pregnant or lactating;
* previous treatment with erythropoietin or other erythropoietic substance;
* blood transfusion within the last 3 months;
* need for dialysis expected in the next 6 months;
* administration of another investigational drug within 30 days preceding study start, or during the study.
B: Inclusion Criteria:

* Patients must have CKD with Hg level \<11 g/dL at study start
* must not have received any erythropoietic agents within 8 weeks of study start
* Patients with reproductive potential and their partners must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, partner sterilization) before entry and throughout the study, female subjects with reproductive potential must have a negative urine pregnancy test within 7 days of the first dose of epoetin alfa
* Patients must have signed informed consent documents indicating that they agree to participate in the study, including the completion of all study-related procedures and evaluations.

Protocol Addendum: Patients must have participated in the Main Protocol of this study and completed all study-related procedures

* Patients must have a Hb between 11-12 g/dL at baseline (measured by HemoCue)
* Patients must have CKD defined as glomerular filtration rate (GFR) \>=15 to \<=90 mL/min as determined using the Modification of Diet for Renal Disease (MDRD) equation.

Exclusion Criteria:

* No patients receiving dialysis or scheduled to receive dialysis during the course of the study
* No patients with a current diagnosis of poorly controlled hypertension after adequate antihypertensive therapy or those with severe congestive heart failure (New York Heart Association Class IV), or known severe stable or unstable coronary artery disease
* No patients receiving chemotherapy for cancer within 3 months prior to study start or expected during study participation
* No patients with a current diagnosis of anemia due to Vitamin B12 deficiencies, hemolysis, or gastrointestinal bleeding or a history of/or active blood or bleeding disorders (this includes but is not limited to porphyria, thalassemia, myelodysplastic syndrome, and sickle cell anemia. No patients with liver diseases or any other diseases known to cause anemia
* No patients with a past history of thrombotic vascular events, (including but not limited to stroke, transient ischemic attack, myocardial infarction, coronary artery disease, and deep venous thrombosis) within the past 5 years
* No patients with a life expectancy of \<= 6 months
* No women who are currently pregnant or lactating. No patients previously unresponsive to erythropoietic agents.

Protocol Addendum: No patients with a transferrin saturation (TSAT) \<20% and a ferritin \<50 ng/mL

* No patients with an epoetin alfa dose reduction/hold within the past four weeks of treatment in the Main Protocol, for a Hb rate of rise (\>1 g/dL over 1 or 2 consecutive weeks),or a Hb above 12 g/dL
* No patients with iron overload defined as a TSAT \> 70% or a ferritin \> 1000 ng/mL
* No patients with a serum albumin concentration \< 2.6 g/dL, or unstable angina
* No patients with chemotherapy for cancer within 3 months prior to baseline or expected during open-label extension participation
* No patients with known solid tumor malignancy or with new onset seizures within 3 months or seizures not controlled by medication prior to baseline. No patients receiving transfusion of platelets or packed red blood cells within 28 days prior to the first dose of epoetin alfa. No patients who have been previously unresponsive to erythropoietic agents, including patients who were treatment failures during the Main Protocol.
C: Inclusion Criteria:

* Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
* Require support of an erythropoietin receptor agonist

Exclusion Criteria:

* Uncontrolled hypertension
* Serum ferritin level less than 50 ng/mL
* Serum iron overload
* Severe congestive heart failure
* Active infection
D: Inclusion Criteria:

* Chronic Kidney Disease:Glomerular filtration rate (GFR) \> 15 mL/min and \> 50 mL/min as calculated by the central lab. HB\<11 g/dL upon study enrollment. The GFR for assessment of patient eligibility will be determined using the formula derived from the Modification of Diet for Renal Disease (MDRD) Study.

Exclusion Criteria:

* Pregnant or lactating women
* Presence of uncontrolled hypertension
* Known hypersensitivity to mammalian cell-derived products or human albumin
* Active gastrointestinal bleeding
* Iron overload defined as a transferrin saturation \>70% or ferritin \>1000 ng/mL
* History of frequent blood transfusions in the past 6 months
* Unstable angina or angina pectoris at rest
* Severe chronic obstructive pulmonary disease requiring routine use of supplemental oxygen
* Severe liver dysfunction that is defined by an international normalized ratio \>2.0, not caused by an anticoagulant
* Severe malnutrition
* Active hematological disease (eg, sickle cell anemia, thalassemia)
* Active malignancy (usually defined as malignancy requiring current chemotherapy or radiotherapy)
* Patients with current seizure disorder or activity
* Patients currently receiving RRT (patient can not be on dialysis or have had a kidney transplant)
* Patients who have received Epoetin Alpha within 6 weeks prior to study entry

Answer: A