Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Multi-Center, Open Label Trial to Establish the Therapeutic Equivalence Between GerEpo and Eprex® and to Determine the Long Term Safety Profile of GerEpo in Patients on Hemodialysis.
Brief Summary: The purpose of the study is to establish the equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response and to establish the longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event


Options:
A: 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
B: Inclusion Criteria:

1. Written informed consent obtained.
2. Patients age between 18 and 70 years.
3. Patients who are medically stable on hemodialysis for a minimum of 3 months.
4. Patients on Eprex® treatment for CRF related anemia and maintaining Hb level at or above 9 g/dL(90g/L) while on a stable dose (no change in dose) of Epoetin within 6 weeks preceding the screening phase of this study.
5. Patients who have a serum ferritin level greater than 100μg/L and/or transferrin saturation at least 20% within 3 months preceding the screening phase of this study.

Exclusion Criteria:

1. Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, IUD or diaphragms in conjunction with spermicidal foam and condom on the male partner.
2. Participation in any drug trial in which the patient received an Epoetin investigational drug within 30 days preceding the screening phase of this study.
3. Those persons directly involved in the conduct of the study.
4. Poorly controlled hypertension with diastolic blood pressures persistently greater than 110 mmHg at baseline observation.
5. History of seizure disorder.
6. Active acute or chronic infection or inflammatory disease.
7. Any illness that had required hospitalization within the last one month.
8. Had blood transfusion within the last three months.
9. Significant hematologic abnormalities (Evidence of hemolysis by laboratory tests, unexplained acquired microcytosis, thrombocytosis (\>500,000/mm3))
10. Severe hyperparathyroidism
11. Diagnosed to have malignant tumor or who have residual tumor after anti-cancer therapy.
C: Inclusion Criteria:

* adult patients \>=18 years of age;
* type 1 or type 2 diabetes;
* stable glycemic control for \>=3 months;
* diabetic nephropathy.

Exclusion Criteria:

* women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;
* previous treatment with erythropoietin or other erythropoietic substance;
* nondiabetic renal disease, nephrotic syndrome;
* blood transfusion within the 3 months prior to enrollment;
* administration of any investigational drug within 30 days preceding the study start, and during the study.
D: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving IV epoetin for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.

Answer: B