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:

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.
B: Inclusion Criteria

Subjects eligible to be entered into the study will meet all of the following criteria:

1. Adult female or male subjects; age ≥ 18 years.
2. End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥ 120 days.
3. Diagnosed with anemia.
4. Administered routine Epogen therapy for at least 16 weeks by an IV route for treatment of anemia using an Epogen version of an FMCNA dosing algorithm for ESA, and did not miss more than 3 prescribed doses of Epogen within 12 weeks prior to randomization.
5. Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of versions 5.0, 5.1, ...) for anemia management.
6. Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that is the FMCNA standard of care treatment for iron replacement.

Exclusion Criteria

Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:

1. Subjects unable to provide a signed and dated informed consent for this clinical research study.
2. As determined by the Investigator, female subjects of child bearing potential who do not agree to use a highly effective method of contraception.
3. Any condition as determined by the investigator that would place a subject at an increased risk, or preclude subject's full compliance with the study procedures and visits.
4. Female subjects who are known to be or found to be, pregnant or lactating.
5. Subjects that are not a candidate for ESA therapies per the label warnings listed in the package insert for Epogen and/or contraindications to Epoetin Hospira listed in the Investigators' Brochure; or have had a known positive test for anti-rhEPO antibodies.
6. Treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial.
7. Diagnosed with any concurrent condition that could lead to greater-than-normal loss of blood, including but not limited to:

   * Menorrhagia, peptic ulcer disease, gastrointestinal bleeding, blood dyscrasia, hemoglobinopathy
   * Use of anticoagulation therapy, including warfarin with a target international normalized ratio (INR) of 2 or greater Anti-platelet therapy (e.g. aspirin or clopidogrel) is permitted, as is heparin given during hemodialysis. Low-dose warfarin is permitted and defined as the presence of at least two INR values less than or equal to 1.5 during the 120 days prior to enrollment and no values exceeding 1.5 at any time after 120 days prior to enrollment.

   Subjects started on warfarin with a known INR goal of 2.0 or greater are to receive no further treatment with the study drugs, but follow up visits can continue.

   Subjects on warfarin who meet criteria to enter the study are terminated if an INR \> 2.0 is discovered or if no INR is available for 60 days.
8. History of transfusion of any blood product in the past 3 months, or 2 or more transfusions in the past 1 year; or donated or lost \> 475 mL blood volume (including plasmapheresis) in the past 3 months.
9. Subjects currently receiving a long acting ESA, or who have received a long acting ESA in the 16 weeks prior to study randomization
C: Inclusion Criteria:

* Heart failure of at least 3 months duration and of New York Heart Association (NYHA) class II, III, or IV
* hemoglobin between 9.0 g/dL and 12.0 g/dL
* left ventricular ejection fraction equal to or less than 40%

Exclusion Criteria:

* Transferrin saturation (Tsat) \< 15%
* Blood pressure \> 160/100 mm Hg
* Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization
* Recipient of a major organ transplant or receiving renal replacement therapy
* Serum creatinine \> 3.0 mg/dL (\> 265 µmol/L)
D: Inclusion Criteria:

* Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative \[KDOQI\] stage III-V).
* Stable on and taking doses \<= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
* Transferrin saturation \>= 20% and ferritin \>= 100 ng/mL.

Exclusion Criteria:

* Uncontrolled hypertension.
* Requiring doses of EPO \> 10,000 IU/week.
* Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
* Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
* Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
* Androgen therapy in the 30 days immediately prior to randomisation in the study.
* Known Human Immunodeficiency Virus(HIV)infection.
* History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.

Answer: A