Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open, Randomized, Multi-centre Trial to Investigate the Effect of Anemia Correction on Cardiac Structure and Function in Patients With Early Diabetic Nephropathy
Brief Summary: This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Options:
A: Inclusion Criteria:

* adult patients \>=18 years of age;
* type 1 or type 2 diabetes;
* stable glycemic control for \>=3 months;
* diabetic nephropathy.

Exclusion Criteria:

* women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;
* previous treatment with erythropoietin or other erythropoietic substance;
* nondiabetic renal disease, nephrotic syndrome;
* blood transfusion within the 3 months prior to enrollment;
* administration of any investigational drug within 30 days preceding the study start, and during the study.
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:

* 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.
D: Inclusion Criteria:

* Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative \[KDOQI\] stage III-V).
* Stable on and taking doses \<= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
* Transferrin saturation \>= 20% and ferritin \>= 100 ng/mL.

Exclusion Criteria:

* Uncontrolled hypertension.
* Requiring doses of EPO \> 10,000 IU/week.
* Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
* Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
* Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
* Androgen therapy in the 30 days immediately prior to randomisation in the study.
* Known Human Immunodeficiency Virus(HIV)infection.
* History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.

Answer: A