Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Subcutaneous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Not on Dialysis
Brief Summary: The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.


Options:
A: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

* overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
* transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
* active malignancy;
B: * Inclusion Criteria

  1. Patients with 19 years of age or older
  2. Patients with chronic renal failure of stage 3 or above who are not on dialysis
  3. Patients with the Hb levels of 8 to 10g/dl measured at screening
  4. Patients with enough body iron stores who meet the following item:

     -Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
  5. Patients who have provided written consent to participate in the clinical trial voluntarily
* Exclusion Criteria

  1. Patients who are expected to need dialysis within a year or patients with rapidly progressive chronic renal failure
  2. Patients who have received drug treatment such as erythropoiesis stimulating agent for the purpose of correcting anemia within 12 weeks prior to screening
  3. Patients who have received red blood cell transfusion within 12 weeks prior to screening
  4. Patients with uncontrolled hypertension
  5. Patients who had hypersensitivity to erythropoietin agents
  6. Patients who had known hypersensitivity to mammalian cell-derived products or additives
  7. Patients with history of severe cardiovascular diseases
  8. Patients whose anemia is not caused by chronic renal failure or may affect anemia correction including the following conditions:
  9. Patients whose AST/ALT test results performed at screening exceeds twice of normal upper limit
  10. Patients who have experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
C: Inclusion Criteria:

* chronic patients aged 18 years or older, undergoing dialysis 3 times a week for at least 8 weeks before screening, necessitating continuous subcutaneous treatment with weekly Darbepoetin alfa or Erythropoietin beta to maintain hemoglobin (Hb) targets

Exclusion Criteria:

* pregnancy; not respecting the inclusion criteria
D: 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.

Answer: B