Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis.

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