Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Condition: Renal Insufficiency, Chronic; Anemia; Renal Dialysis; Erythrocyte Transfusion
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Intervention: Epoetin alfa
Intervention description: Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Anemia; Hemodialysis; Red Blood Cell Transfusion

Summary:

      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.
    

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