<br>        Inclusion Criteria:<br><br>          1. Age and weight: >/= 18 years of age and >/= 45 kg.<br><br>          2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or<br>             peritoneal dialysis) or dialysis planned during the time the subject would be enrolled<br>             in the study.<br><br>          3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their<br>             biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),<br>             peginesatide or their biosimilars..<br><br>          4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal<br>             Disease (MDRD).<br><br>          5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.<br><br>          6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).<br><br>          7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.<br><br>          8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.<br><br>          9. TSAT within the reference range.<br><br>         10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if<br>             required, that will be maintained throughout the study. NOTE: IV iron replacement<br>             therapy is not allowed the two weeks prior to Screening through the end of the study<br>             (Week 6).<br><br>         11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at<br>             Screening Visit, based on Central Reader's interpretation.<br><br>         12. Females: Eligible to participate if she is of childbearing potential, and must agree<br>             to use approved contraception methods from Screening until completion of the Follow-up<br>             Visit OR of non-childbearing potential defined as pre-menopausal females with a<br>             documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of<br>             spontaneous amenorrhea [in questionable cases a blood sample with simultaneous<br>             follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].<br>             Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will<br>             be required to use one of the approved contraception methods if they wish to continue<br>             their HRT during the study. Otherwise they must discontinue HRT to allow confirmation<br>             of post-menopausal status prior to study enrollment. For most types of HRT, at least 2<br>             weeks will elapse between the cessation of therapy and the blood draw; this interval<br>             depends on the type and dosage of HRT. Following confirmation of their post-menopausal<br>             status, they can resume use of HRT during the study without use of a contraceptive<br>             method.<br><br>         13. Males: Must agree to use approved contraceptive methods from the time of Screening<br>             until completion of the Follow-up Visit.<br><br>        Exclusion Criteria:<br><br>          1. Dialysis: Planning to initiate dialysis during the study or who have a high potential<br>             for initiating dialysis during study participation.<br><br>          2. Renal transplant: Renal transplant anticipated or scheduled within the study time<br>             period or subjects with a functioning renal transplant.<br><br>          3. Total CPK: >5x the upper limit of the reference range.<br><br>          4. HIV: Positive HIV antibody.<br><br>          5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.<br><br>          6. History of stroke or TIAs.<br><br>          7. Heart failure: Class III/IV heart failure, as defined by the New York Heart<br>             Association (NYHA) functional classification system.<br><br>          8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or<br>             lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.<br><br>          9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as<br>             deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset<br>             or worsening limb ischemia requiring intervention), or other thrombosis related<br>             condition) within the prior 6 months.<br><br>         10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than<br>             normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,<br>             significant heart failure or lung disease requiring supplemental oxygen, or those with<br>             connective tissue diseases).<br><br>         11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis<br>             (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac<br>             disease).<br><br>         12. Hematological disease: Any hematological disease including those affecting platelets,<br>             the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.<br>             sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,<br>             hemolytic anemia) or any other cause of anemia other than renal disease.<br><br>         13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the<br>             exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening<br>             of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit<br>             of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that<br>             in the opinion of the investigator would preclude the subject from participation in<br>             the study.<br><br>         14. Major surgery: Within the prior 12 weeks or planned during the study.<br><br>         15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for<br>             blood transfusion during the study.<br><br>         16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer<br>             disease or active GI bleeding within the prior 12 weeks.<br><br>         17. Acute infection: Clinical evidence of acute infection or history of infection<br>             requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening<br>             through Day 1 (randomization).<br><br>         18. Malignancy: History of malignancy within 5 years of Screening or are receiving<br>             treatment for cancer or those with a strong family history of cancer (e.g., familial<br>             cancer disorders), with the exception of squamous cell or basal cell carcinoma of the<br>             skin that has been definitively treated.<br><br>         19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the<br>             Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.<br><br>         20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12<br>             months, or macular edema requiring treatment.<br><br>         21. Severe reactions: History of severe allergic or anaphylactic reactions or<br>             hypersensitivity to excipients in the investigational product.<br><br>         22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary<br>             supplements that are prohibited from Screening until the Follow-up Visit.<br><br>         23. Androgens: New androgen therapy or changes to pr;<br>        Inclusion Criteria:<br><br>          1. Age and weight: >/= 18 years of age and >/= 45 kg.<br><br>          2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or<br>             peritoneal dialysis) or dialysis planned during the time the subject would be enrolled<br>             in the study.<br><br>          3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their<br>             biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),<br>             peginesatide or their biosimilars..<br><br>          4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal<br>             Disease (MDRD).<br><br>          5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.<br><br>          6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).<br><br>          7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.<br><br>          8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.<br><br>          9. TSAT within the reference range.<br><br>         10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if<br>             required, that will be maintained throughout the study. NOTE: IV iron replacement<br>             therapy is not allowed the two weeks prior to Screening through the end of the study<br>             (Week 6).<br><br>         11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at<br>             Screening Visit, based on Central Reader's interpretation.<br><br>         12. Females: Eligible to participate if she is of childbearing potential, and must agree<br>             to use approved contraception methods from Screening until completion of the Follow-up<br>             Visit OR of non-childbearing potential defined as pre-menopausal females with a<br>             documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of<br>             spontaneous amenorrhea [in questionable cases a blood sample with simultaneous<br>             follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].<br>             Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will<br>             be required to use one of the approved contraception methods if they wish to continue<br>             their HRT during the study. Otherwise they must discontinue HRT to allow confirmation<br>             of post-menopausal status prior to study enrollment. For most types of HRT, at least 2<br>             weeks will elapse between the cessation of therapy and the blood draw; this interval<br>             depends on the type and dosage of HRT. Following confirmation of their post-menopausal<br>             status, they can resume use of HRT during the study without use of a contraceptive<br>             method.<br><br>         13. Males: Must agree to use approved contraceptive methods from the time of Screening<br>             until completion of the Follow-up Visit.<br><br>        Exclusion Criteria:<br><br>          1. Dialysis: Planning to initiate dialysis during the study or who have a high potential<br>             for initiating dialysis during study participation.<br><br>          2. Renal transplant: Renal transplant anticipated or scheduled within the study time<br>             period or subjects with a functioning renal transplant.<br><br>          3. Total CPK: >5x the upper limit of the reference range.<br><br>          4. HIV: Positive HIV antibody.<br><br>          5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.<br><br>          6. History of stroke or TIAs.<br><br>          7. Heart failure: Class III/IV heart failure, as defined by the New York Heart<br>             Association (NYHA) functional classification system.<br><br>          8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or<br>             lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.<br><br>          9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as<br>             deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset<br>             or worsening limb ischemia requiring intervention), or other thrombosis related<br>             condition) within the prior 6 months.<br><br>         10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than<br>             normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,<br>             significant heart failure or lung disease requiring supplemental oxygen, or those with<br>             connective tissue diseases).<br><br>         11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis<br>             (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac<br>             disease).<br><br>         12. Hematological disease: Any hematological disease including those affecting platelets,<br>             the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.<br>             sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,<br>             hemolytic anemia) or any other cause of anemia other than renal disease.<br><br>         13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the<br>             exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening<br>             of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit<br>             of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that<br>             in the opinion of the investigator would preclude the subject from participation in<br>             the study.<br><br>         14. Major surgery: Within the prior 12 weeks or planned during the study.<br><br>         15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for<br>             blood transfusion during the study.<br><br>         16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer<br>             disease or active GI bleeding within the prior 12 weeks.<br><br>         17. Acute infection: Clinical evidence of acute infection or history of infection<br>             requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening<br>             through Day 1 (randomization).<br><br>         18. Malignancy: History of malignancy within 5 years of Screening or are receiving<br>             treatment for cancer or those with a strong family history of cancer (e.g., familial<br>             cancer disorders), with the exception of squamous cell or basal cell carcinoma of the<br>             skin that has been definitively treated.<br><br>         19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the<br>             Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.<br><br>         20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12<br>             months, or macular edema requiring treatment.<br><br>         21. Severe reactions: History of severe allergic or anaphylactic reactions or<br>             hypersensitivity to excipients in the investigational product.<br><br>         22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary<br>             supplements that are prohibited from Screening until the Follow-up Visit.<br><br>         23. Androgens: New androgen therapy or changes to pr;<br>        Inclusion Criteria:<br><br>          1. Age and weight: >/= 18 years of age and >/= 45 kg.<br><br>          2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or<br>             peritoneal dialysis) or dialysis planned during the time the subject would be enrolled<br>             in the study.<br><br>          3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their<br>             biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),<br>             peginesatide or their biosimilars..<br><br>          4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal<br>             Disease (MDRD).<br><br>          5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.<br><br>          6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).<br><br>          7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.<br><br>          8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.<br><br>          9. TSAT within the reference range.<br><br>         10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if<br>             required, that will be maintained throughout the study. NOTE: IV iron replacement<br>             therapy is not allowed the two weeks prior to Screening through the end of the study<br>             (Week 6).<br><br>         11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at<br>             Screening Visit, based on Central Reader's interpretation.<br><br>         12. Females: Eligible to participate if she is of childbearing potential, and must agree<br>             to use approved contraception methods from Screening until completion of the Follow-up<br>             Visit OR of non-childbearing potential defined as pre-menopausal females with a<br>             documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of<br>             spontaneous amenorrhea [in questionable cases a blood sample with simultaneous<br>             follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].<br>             Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will<br>             be required to use one of the approved contraception methods if they wish to continue<br>             their HRT during the study. Otherwise they must discontinue HRT to allow confirmation<br>             of post-menopausal status prior to study enrollment. For most types of HRT, at least 2<br>             weeks will elapse between the cessation of therapy and the blood draw; this interval<br>             depends on the type and dosage of HRT. Following confirmation of their post-menopausal<br>             status, they can resume use of HRT during the study without use of a contraceptive<br>             method.<br><br>         13. Males: Must agree to use approved contraceptive methods from the time of Screening<br>             until completion of the Follow-up Visit.<br><br>        Exclusion Criteria:<br><br>          1. Dialysis: Planning to initiate dialysis during the study or who have a high potential<br>             for initiating dialysis during study participation.<br><br>          2. Renal transplant: Renal transplant anticipated or scheduled within the study time<br>             period or subjects with a functioning renal transplant.<br><br>          3. Total CPK: >5x the upper limit of the reference range.<br><br>          4. HIV: Positive HIV antibody.<br><br>          5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.<br><br>          6. History of stroke or TIAs.<br><br>          7. Heart failure: Class III/IV heart failure, as defined by the New York Heart<br>             Association (NYHA) functional classification system.<br><br>          8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or<br>             lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.<br><br>          9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as<br>             deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset<br>             or worsening limb ischemia requiring intervention), or other thrombosis related<br>             condition) within the prior 6 months.<br><br>         10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than<br>             normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,<br>             significant heart failure or lung disease requiring supplemental oxygen, or those with<br>             connective tissue diseases).<br><br>         11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis<br>             (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac<br>             disease).<br><br>         12. Hematological disease: Any hematological disease including those affecting platelets,<br>             the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.<br>             sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,<br>             hemolytic anemia) or any other cause of anemia other than renal disease.<br><br>         13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the<br>             exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening<br>             of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit<br>             of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that<br>             in the opinion of the investigator would preclude the subject from participation in<br>             the study.<br><br>         14. Major surgery: Within the prior 12 weeks or planned during the study.<br><br>         15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for<br>             blood transfusion during the study.<br><br>         16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer<br>             disease or active GI bleeding within the prior 12 weeks.<br><br>         17. Acute infection: Clinical evidence of acute infection or history of infection<br>             requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening<br>             through Day 1 (randomization).<br><br>         18. Malignancy: History of malignancy within 5 years of Screening or are receiving<br>             treatment for cancer or those with a strong family history of cancer (e.g., familial<br>             cancer disorders), with the exception of squamous cell or basal cell carcinoma of the<br>             skin that has been definitively treated.<br><br>         19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the<br>             Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.<br><br>         20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12<br>             months, or macular edema requiring treatment.<br><br>         21. Severe reactions: History of severe allergic or anaphylactic reactions or<br>             hypersensitivity to excipients in the investigational product.<br><br>         22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary<br>             supplements that are prohibited from Screening until the Follow-up Visit.<br><br>         23. Androgens: New androgen therapy or changes to pr;<br>        Inclusion Criteria:<br><br>          1. Age and weight: >/= 18 years of age and >/= 45 kg.<br><br>          2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or<br>             peritoneal dialysis) or dialysis planned during the time the subject would be enrolled<br>             in the study.<br><br>          3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their<br>             biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),<br>             peginesatide or their biosimilars..<br><br>          4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal<br>             Disease (MDRD).<br><br>          5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.<br><br>          6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).<br><br>          7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.<br><br>          8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.<br><br>          9. TSAT within the reference range.<br><br>         10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if<br>             required, that will be maintained throughout the study. NOTE: IV iron replacement<br>             therapy is not allowed the two weeks prior to Screening through the end of the study<br>             (Week 6).<br><br>         11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at<br>             Screening Visit, based on Central Reader's interpretation.<br><br>         12. Females: Eligible to participate if she is of childbearing potential, and must agree<br>             to use approved contraception methods from Screening until completion of the Follow-up<br>             Visit OR of non-childbearing potential defined as pre-menopausal females with a<br>             documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of<br>             spontaneous amenorrhea [in questionable cases a blood sample with simultaneous<br>             follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].<br>             Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will<br>             be required to use one of the approved contraception methods if they wish to continue<br>             their HRT during the study. Otherwise they must discontinue HRT to allow confirmation<br>             of post-menopausal status prior to study enrollment. For most types of HRT, at least 2<br>             weeks will elapse between the cessation of therapy and the blood draw; this interval<br>             depends on the type and dosage of HRT. Following confirmation of their post-menopausal<br>             status, they can resume use of HRT during the study without use of a contraceptive<br>             method.<br><br>         13. Males: Must agree to use approved contraceptive methods from the time of Screening<br>             until completion of the Follow-up Visit.<br><br>        Exclusion Criteria:<br><br>          1. Dialysis: Planning to initiate dialysis during the study or who have a high potential<br>             for initiating dialysis during study participation.<br><br>          2. Renal transplant: Renal transplant anticipated or scheduled within the study time<br>             period or subjects with a functioning renal transplant.<br><br>          3. Total CPK: >5x the upper limit of the reference range.<br><br>          4. HIV: Positive HIV antibody.<br><br>          5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.<br><br>          6. History of stroke or TIAs.<br><br>          7. Heart failure: Class III/IV heart failure, as defined by the New York Heart<br>             Association (NYHA) functional classification system.<br><br>          8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or<br>             lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.<br><br>          9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as<br>             deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset<br>             or worsening limb ischemia requiring intervention), or other thrombosis related<br>             condition) within the prior 6 months.<br><br>         10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than<br>             normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,<br>             significant heart failure or lung disease requiring supplemental oxygen, or those with<br>             connective tissue diseases).<br><br>         11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis<br>             (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac<br>             disease).<br><br>         12. Hematological disease: Any hematological disease including those affecting platelets,<br>             the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.<br>             sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,<br>             hemolytic anemia) or any other cause of anemia other than renal disease.<br><br>         13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the<br>             exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening<br>             of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit<br>             of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that<br>             in the opinion of the investigator would preclude the subject from participation in<br>             the study.<br><br>         14. Major surgery: Within the prior 12 weeks or planned during the study.<br><br>         15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for<br>             blood transfusion during the study.<br><br>         16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer<br>             disease or active GI bleeding within the prior 12 weeks.<br><br>         17. Acute infection: Clinical evidence of acute infection or history of infection<br>             requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening<br>             through Day 1 (randomization).<br><br>         18. Malignancy: History of malignancy within 5 years of Screening or are receiving<br>             treatment for cancer or those with a strong family history of cancer (e.g., familial<br>             cancer disorders), with the exception of squamous cell or basal cell carcinoma of the<br>             skin that has been definitively treated.<br><br>         19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the<br>             Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.<br><br>         20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12<br>             months, or macular edema requiring treatment.<br><br>         21. Severe reactions: History of severe allergic or anaphylactic reactions or<br>             hypersensitivity to excipients in the investigational product.<br><br>         22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary<br>             supplements that are prohibited from Screening until the Follow-up Visit.<br><br>         23. Androgens: New androgen therapy or changes to pr