Please select the eligibility criteria that correspond to the clinical trial below.
Title: Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
Brief Summary: Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. The benefit of reducing the administration interval was however lessened by the variability induced by more frequent dosage adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under different ESAs and administration intervals in a collective of chronic hemodialysis patients.

Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.


Options:
A: 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
B: 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.
C: Inclusion Criteria:

* regular long term hemodialysis with same schedule for greater than or equal to (\>=) 12 weeks
* continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months
* significant acute or chronic bleeding
* poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months
* weekly dose of epoetin beta greater than (\>) 16000 international units (IU), or weekly dose of darbepoetin alfa \>80 micrograms during previous month
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: A