Intervention: rhEPO
Trial phase: Phase 4
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Eligibility criteria:
Inclusion Criteria:

Informed consent obtained prior to initiation of any study-specific activities/procedures
Age 18 or older
Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization
Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization
Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and < 90,000 Units/week (ie, < 30,000 Units/administration) of epoetin alfa during the 4 weeks prior to randomization
Received ≥ 4 doses of epoetin alfa during the 2 weeks prior to randomization
Hemoglobin concentration ≤ 11.0 g/dL, per the most recent local laboratory value obtained during the 2 weeks prior to randomization
Hemoglobin concentration ≤ 11.0 g/dL, at the screening visit, using the hemoglobin point of care device provided by Amgen
Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the most recent local laboratory value obtained during the 4 weeks prior to randomization

Exclusion Criteria:

Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to randomization
Other investigational procedures while participating in this study are excluded
Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy or biologics) within 5 years of randomization, with the exception of locally excised non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
Subject is currently pregnant or planning to become pregnant during treatment and for 30 days after the end of treatment
Subject is currently breast feeding or planning on breast feeding during treatment and for 30 days after the end of treatment
Females of reproductive potential who are not willing to use an acceptable method of effective contraception during treatment and for at least 30 days after the end of treatment
Currently receiving IV antibiotics
Currently receiving systemic immunosuppressive therapy known to cause anemia, including treatment for active hepatitis (eg, azathioprine, mycophenolate mofetil, ≥ 10 mg prednisone [or equivalent]/day, interferon)
Known human immunodeficiency virus (HIV) positive
Known neutralizing anti-erythropoietic protein antibodies
Known sensitivity to epoetin alfa
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, planned vacations where away from dialysis unit for more than 2 weeks) to the best of the subject and investigator's knowledge
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Previously entered this study

Occurrence of any of the following within 8 weeks prior to randomization:

Seizure
Clinically relevant active bleeding (eg, gastrointestinal bleed)
RBC transfusion
Any hospitalization or observational stay > 24 hours
Uncontrolled hypertension, per the investigator within the 4 weeks prior to randomization
Expected or scheduled solid organ transplant(eg, kidney) within 40 weeks after randomization
Expected or scheduled to change dialysis modality (eg, peritoneal dialysis, home hemodialysis) within 40 weeks after randomization