Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double-blind Study to Assess the Impact of Normalization of Hemoglobin Compared to Partial Correction of Hemoglobin With EPREX�/ERYPO� on Left Ventricular Structure in Early Hemodialysis Patients (RWJ-22512)
Brief Summary: The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function.


Options:
A: Inclusion Criteria:

* Aged between 18 and 70
* ESRD patients who are on hemodialysis for ≥3 months.
* Hb level 8- 11.5 g/dl
* Patients are on adequate hemodialysis: the minimally adequate dose of hemodialysis given 3 times per week should be a spKt/V (single-pool delivered Kt/V; clearance of urea x dialysis time/volume of distribution) of 1.2 per dialysis. For treatment periods of less than 5 hours, an alternative minimum dose is a urea reduction rate (URR) of 65%. All types of hemodialysis systems and hemodiafiltration, including high-flux membranes are allowed as long as there is no plan to change the patient's regimen during the study.
* Sufficient iron stores, defined as serum ferritin ≥ 200 ng/ml and transferrin saturation ≥20%. (Patients not meeting these criteria may receive iron supplementation therapy during the Screening and stabilization period to appropriately correct their iron store deficiency to meet the criterion required for randomization);
* Ability to comply with study medication use, study visits, and study procedures as judged by the investigator;
* Females of childbearing potential agree to use an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) for the duration of the study.
* Qualified and willing to sign the informed consent form with the commitment of complying with all the scheduled visits, and study procedures as judged by the investigator;
* In any circumstances that potential participants are not able to give consent, it may be given by responsible parents or guardian.

Exclusion Criteria:

* Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥180 mmHg);
* Anemia secondary to other causes different to the CKD (e.g. multiple myeloma, aplastic anemia, leukemia;....)
* Decompensated liver failure;
* Clinical evidence of concurrent uncontrolled hyperparathyroidism (defined as serum parathyroid hormone (iPTH) \> 800 pg/ml);
* Heart failure \[New York Heart Association (NYHA) class III and IV\];
* Unstable angina pectoris, active cardiac disease, stroke and/or cardiac infarction within the last 6 months;
* History of or active blood coagulation disorders including DVT, PTE, native access Thrombosis during last 6 months.
* Thrombocytosis (platelet count \> 500,000/µl);
* Thrombocytopenia (platelet count \< 100,000/µl);
* White blood cell count \< 3,000/µl);
* White blood cell count \>15,000/µl)
* Recent Bleeding (acute or chronic bleeding within three months prior to screening);
* Suspicion of or confirmed occult bleeding (increased reticulocyte count);
* Clinical evidence of concurrent systemic infection, or inflammatory disease (e.g; diabetic foot, bed sore, access infection, CRP\> 30 mg/l,...)
* Currently receiving treatment for epilepsy;
* Major surgery within 3 months prior to randomization and during the conduct of the trial (except vascular access surgery);
* Concomitant immunosuppressive therapy; patients on a short course of steroids (up to 7 days), topical or intranasal steroids are allowed in the study;
* History of any malignant disease within the last 5 years (except excised non-melanoma skin cancer);
* Women who are pregnant or breastfeeding;
* Known history of severe drug-related allergies;
* Known history of drug related allergy to Erythropoietin or one of the ingredients of the test or the reference products or hypersensitivity to mammalian-derived products;
* Transplant received within one year prior to the start of the study;
* Simultaneous participation in another clinical study or having received an Investigational Medicinal Product within three months before randomization in this study.
* Psychiatric, addictive (drugs or alcohol) or any other disorder that compromises the ability to give an informed consent;
* Any red blood cell transfusion during the last 3 months (measured at the time of eligibility verification);
* Primary hematological disorder (e.g. myelodysplastic syndrome, myeloma, sickle cell anemia, hematological malignancy, multiple myeloma hemolytic anemia);
* known resistance to the rHuEPO defined by a requirement \> 450 IU/kg/week by IV or 300 IU/kg/week by SC, equivalent to approximately 20.000 IU/week SC and in absence of iron deficiency;
* who have suffered an event of active bleeding in the 30 days prior to the beginning of the study;
* Morbid obesity, defined by a Body Mass Index (BMI) \> 37 kg/m2 in women and \> 40 kg/m2 in men.
B: Inclusion Criteria:

* On hemodialysis for 3 to 18 months and expected to remain on hemodialysis for at least two more years and with a life expectancy of a year or more
* Kidney transplant patients, whose transplant has failed, and now have been on hemodialysis for 3-18 months, may be eligible for the study, if they are not receiving excessive immunosuppression (e.g., \<=10 mg of steroids/day allowed)
* Pre-dialysis hemoglobin 8-12 g/dL, inclusive, within the previous month (single reading is sufficient)
* Stable hemodialysis vascular access, within the previous 3 months
* No heart disease or asymptomatic heart disease without enlarged heart

Exclusion Criteria:

* Heart diseases for which surgical intervention occurred during the previous two years or which may require intervention within the next year
* Patients with medical conditions likely to affect the response to epoetin
* Predialysis sitting diastolic blood pressure \>= 100 mmHg on average for the previous month
* Folate, Vitamin B12, or transferrin deficiency
* History of seizure within 1 year
* Transfusion within 30 days prior to study entry.
C: Inclusion Criteria:

* End stage renal disease
* Regular dialysis treatment
* Renal anemia (hemoglobin\<9.0 g/dl)
* Age \> 18 years
* Adequate iron stores (TIBC saturation \> 20%, ferritin \>200)

Exclusion Criteria:

* Signs of bleeding
* Major surgery in previous 60 days
* Hemolysis
* Other causes of anemia
* Cancer
* Inflammatory diseases
D: Inclusion Criteria:

* adult patients, \>18 years of age;
* patients with renal anemia or post-transplant anemia.

Exclusion Criteria:

* poorly controlled hypertension;
* known hypersensitivity to NeoRecormon or darbepoetin alfa.

Answer: B