Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease

Inclusion Criteria:

• Patients older than 18 years

• Patients with pre-dialysis chronic renal failure (CRF) defined by a glomerularfiltration rate (calculated with the Modification of Diet in Renal Disease Studyformula) ≥15 ml/ min and <60 ml/ min, by 1.73 m2

• Anemic patients that should be treated and levels of hemoglobin <10.5 g/dl and ≥ 7.5g/dl.

• Patients that have the will and capacity to sign a written inform consent.

• Post-menopause women for at least 2 years, or sterile by surgery for at least 6months. Women of childbearing age must have a negative pregnancy test at baselineand be willing to get an adequate method of contraception.

Exclusion Criteria:

• Patients that are planned to be on dialysis or have a renal transplant in thefollowing 6 months.

• Transferrin iron Saturation < 20%.

• Etiology of renal failure (as secondary to autoimmune diseases) that, to the judgeto the physician, can affect the normal development of the protocol.

• Active bleeding or history of hemorrhage that have led to a significative decreaseof hematocrit in the last 30 days.

• Non-controlled hypertension (≥160 mm Hg of systolic pressure and/or ≥100 mm Hg ofdiastolic pressure with anti-hypertensive treatment).

• Anemia caused by any other cause than renal disease.

• Having a transfusion in the last 3 months before basal visit or during screening.

• Treatment with an erythropoiesis stimulant in the last 3 months before basal visitor screening.

• Increase risk of thromboembolic disease: history of arterial thromboembolia (stroke,transient ischemic attack, Acute coronary syndrome, etc.) in the last 6 months orvenous in the last 12 months before screening; surgery in the last month beforescreening; prolong immobilization or orthopedic surgery programmed in the following 6 months or any other condition that to the judge of the investigator can increasethe risk of thromboembolism.

• Hematological disease or myelodysplastic syndrome or history of hematologicalneoplasm or solid tumor in the last 5 years.

• History of congestive heart failure

• Pregnancy or breast feeding

• Refuse to participate in the protocol or any medical condition, that in theinvestigator opinion, is significant to prevent the participant from being includedin the trial.