Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of the Efficacy of Erythropoietin Produced in the Institute of Technology in Immunobiology of the Oswald Cruz Foundation (BioMaguinhos/FioCruz/MS) and Erythropoietin Industrialized in Patients With Chronic Renal Failure
Brief Summary: A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis


Options:
A: Inclusion Criteria:

* We included adult patients with chronic renal failure on hemodialysis for more than three months at the Dialysis Unit of the Department of Nephrology, HCPA and the Center for Dialysis and Transplant (CDT), characterized as as patients on chronic regular dialysis procedure. Patients already in use of EPO for at least three months, only those taking the drug by subcutaneous and agreed to participate in the study.

Patients using different doses of EPO were included, but these were distributed across the treatment groups by randomization stratum dose of EPO, to ensure even distribution of patients in both groups.

It was considered that patients with HIV or AIDS who were in treatment for the disease with proper clinical management would be eligible for the study (as exemplified by patients with HIV or AIDS approved for inclusion on the waiting list for cadaveric kidney transplantation) .

Patients with a history of cancer or already treated in the oncological standpoint, and no signs of disease activity could be included.

Exclusion Criteria:

* Patients who had other causes of anemia defined for maintenance, for example, patients with liver cirrhosis, with a history of gastrointestinal bleeding, patients with chronic Gastro Intestinal, Genital or Urinary bleeding or other sites were excluded. Similarly patients with AIDS without treatment, hemolytic anemia, pancytopenia, thalassemia, sickle cell anemia, myelodysplasia, multiple myeloma or other cancers or inflammatory arthritis. There was also no inclusion of patients with intolerance or allergy to iron parenterally, patients without adherence to dialysis or with chronic inadequate dialysis blood flow of vascular access persistently below 250 mL / min, kt / v, as a measure of efficiency of hemodialysis, persistently \<1.2) or frequent hospitalizations considered as possible causes of inadequate response to erythropoietin.

We excluded patients with mental illness or condition that prevents the free consent and signature of informed consent, as well as previous reports of serious adverse effects to the drugs studied.

Criteria for withdrawal from the clinical trial: a view of the high morbidity of hemodialysis patients, expressed by frequent hospital clinics, it was found that patients in the study would not be withdrawn from the study due to hospitalization, provided that: the hospital did not involve surgery (except vascular access surgery or hospitalization in the intensive care unit or equivalent, or that represent otherwise, a loss of patient follow-up or co-interventions in the treatment of anemia of these).

Were withdrawn from the study patients who required blood transfusion because they have severe anemia or intervention unrelated to the usual treatment of anemia in hemodialysis patients.
B: Inclusion Criteria:

* Male or female participants with symptomatic anemia associated with CKD
* Participants with renal anemia who are not treated with an ESA:
* Anemia was defined as hemoglobin (Hb) concentration less than (\<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
* Participants with renal anemia who are on maintenance ESA therapy:
* If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
* Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
* Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent

Exclusion Criteria:

* Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
* Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
* History of hemoglobinopathy
* Anemia due to hemolysis
* Pure red cell aplasia
* High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
* Pregnancy or breast-feeding
* Women of childbearing potential without effective contraception
* Administration of another investigational drug within 1 month before screening or planned during the study period
C: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia;
* maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before screening, and during screening period.

Exclusion Criteria:

* previous therapy with epoetin within 8 weeks prior to screening;
* overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
* RBC transfusions within 8 weeks before screening or during screening period;
* active malignant disease except non-melanoma skin cancer.
D: Inclusion Criteria:

* Patients must have CKD with Hg level \<11 g/dL at study start
* must not have received any erythropoietic agents within 8 weeks of study start
* Patients with reproductive potential and their partners must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, partner sterilization) before entry and throughout the study, female subjects with reproductive potential must have a negative urine pregnancy test within 7 days of the first dose of epoetin alfa
* Patients must have signed informed consent documents indicating that they agree to participate in the study, including the completion of all study-related procedures and evaluations.

Protocol Addendum: Patients must have participated in the Main Protocol of this study and completed all study-related procedures

* Patients must have a Hb between 11-12 g/dL at baseline (measured by HemoCue)
* Patients must have CKD defined as glomerular filtration rate (GFR) \>=15 to \<=90 mL/min as determined using the Modification of Diet for Renal Disease (MDRD) equation.

Exclusion Criteria:

* No patients receiving dialysis or scheduled to receive dialysis during the course of the study
* No patients with a current diagnosis of poorly controlled hypertension after adequate antihypertensive therapy or those with severe congestive heart failure (New York Heart Association Class IV), or known severe stable or unstable coronary artery disease
* No patients receiving chemotherapy for cancer within 3 months prior to study start or expected during study participation
* No patients with a current diagnosis of anemia due to Vitamin B12 deficiencies, hemolysis, or gastrointestinal bleeding or a history of/or active blood or bleeding disorders (this includes but is not limited to porphyria, thalassemia, myelodysplastic syndrome, and sickle cell anemia. No patients with liver diseases or any other diseases known to cause anemia
* No patients with a past history of thrombotic vascular events, (including but not limited to stroke, transient ischemic attack, myocardial infarction, coronary artery disease, and deep venous thrombosis) within the past 5 years
* No patients with a life expectancy of \<= 6 months
* No women who are currently pregnant or lactating. No patients previously unresponsive to erythropoietic agents.

Protocol Addendum: No patients with a transferrin saturation (TSAT) \<20% and a ferritin \<50 ng/mL

* No patients with an epoetin alfa dose reduction/hold within the past four weeks of treatment in the Main Protocol, for a Hb rate of rise (\>1 g/dL over 1 or 2 consecutive weeks),or a Hb above 12 g/dL
* No patients with iron overload defined as a TSAT \> 70% or a ferritin \> 1000 ng/mL
* No patients with a serum albumin concentration \< 2.6 g/dL, or unstable angina
* No patients with chemotherapy for cancer within 3 months prior to baseline or expected during open-label extension participation
* No patients with known solid tumor malignancy or with new onset seizures within 3 months or seizures not controlled by medication prior to baseline. No patients receiving transfusion of platelets or packed red blood cells within 28 days prior to the first dose of epoetin alfa. No patients who have been previously unresponsive to erythropoietic agents, including patients who were treatment failures during the Main Protocol.

Answer: A