Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia
Brief Summary: This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.


Options:
A: 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.
B: Inclusion Criteria:

* chronic renal anemia;
* continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
* regular hemodialysis for greater than or equal to (\>=) 3 months

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months
* poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;
C: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period;
* continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* hemolysis;
* folic acid and vitamin B12 deficiency.
D: Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
* Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
* Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding
* Active malignant disease (except non-melanoma skin cancer)

Answer: B