Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa
Brief Summary: The purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.


Options:
A: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of any investigational drug within 4 weeks before screening.
B: Inclusion Criteria:

* age ≥19 years
* receiving in-center hemodialysis two or more times weekly
* anemia requiring erythropoiesis stimulating (ESA) agent therapy OR a hemoglobin(Hb)\<100g/L in the absence of other causes of anemia
* if female, must be using an approved method of contraception or judged unable to become pregnant
* able to give informed consent

Exclusion Criteria:

* acute kidney injury likely to resolve
* plans to change to peritoneal dialysis or home hemodialysis, or planned transplant from a living donor
* expected lifespan of less than six months due to a medical condition other than chronic kidney disease
* current hematologic condition that may cause anemia
* use of medications known to cause anemia
* use of any investigational drug or androgen within 90 days of screening
* significant bleeding within 30 days of screening
* red blood cell transfusion(s) within 30 days of screening
* documented or suspected pure red cell aplasia (PRCA)
* current iron deficiency
* documented allergy or intolerance to intravenous sodium ferric gluconate
* known or probable ESA resistance
* uncontrolled hypertension
* an intention to relocate to a different dialysis center in the near future
C: Inclusion Criteria:

* Patients with moderate renal failure (glomerular filtration rate \[GFR\] by Cockroft formula of 20-70 ml/min)
* Patients with heart failure NYHA class II-III-IV
* Hemoglobin (Hb) between 6.4 - 7.8 mmol/L in men and between 6.0 - 7.4 mmol/L in women
* Age \> 18 years, \< 80 years
* Written informed consent must be obtained from the subject or legally accepted representative before study-specific procedures, including screening procedures, are performed.

Exclusion Criteria:

* Therapy within 1 year before randomisation or any planned erythropoietic therapy between randomisation and study day 1
* Known intolerance to EPO administration
* Previously suspected of or confirmed to have neutralizing antibodies to recombinant human erythropoietin (rHuEPO)
* Uncontrolled hypertension (RR \> 160 systolic, \>100 diastolic)
* Forms of secondary hypertension other than renal hypertension
* Uncontrolled diabetes (HbA1c \> 8.0 %)
* Primary dyslipidemia
* Kidney transplantation
* Proteinuria \> 3.5 g/L
* Acute renal failure or rapidly progressive glomerulonephritis
* Hyperparathyroidism (parathyroid hormone \[PTH\] \> 40)
* Bleeding or haemolysis as a cause of anaemia
* Deficiency of iron, folate, and/or vitamin B12
* Presence of chronic inflammatory disease or clinically significant infection
* Haematologic malignancy or solid tumour \< 5 years ago
* Chronic liver disease
* Haemoglobinopathies
* Alcohol and/or drug abuse
* Enrolment in another study
* Child bearing potential (pre-menopausal woman who is not using adequate contraceptive precautions)
* Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
D: Inclusion Criteria:

* adult patients, \> or = 18 years of age;
* kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
* functioning graft of \> 6 months and \< 10 years after kidney transplantation, with no signs of acute rejection;
* stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* need for dialysis therapy expected in next 6 months.

Answer: B