A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Epoetin Hospira Arm; Standard of Care Arm; IV Iron
Intervention description: Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.; Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period.; Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira
      Epoetin and Standard of Care Epogen.
    

Eligibility criteria:

        Inclusion Criteria

        Subjects eligible to be entered into the study will meet all of the following criteria:

          1. Adult female or male subjects; age ≥ 18 years.

          2. End stage renal disease subjects treated in-center with the modality of hemodialysis
             for ≥ 120 days.

          3. Diagnosed with anemia.

          4. Administered routine Epogen therapy for at least 16 weeks by an IV route for treatment
             of anemia using an Epogen version of an FMCNA dosing algorithm for ESA, and did not
             miss more than 3 prescribed doses of Epogen within 12 weeks prior to randomization.

          5. Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of
             versions 5.0, 5.1, …) for anemia management.

          6. Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that
             is the FMCNA standard of care treatment for iron replacement.

        Exclusion Criteria

        Subjects that meet any of the following criteria will be ineligible to be entered into the
        interventional cohort:

          1. Subjects unable to provide a signed and dated informed consent for this clinical
             research study.

          2. As determined by the Investigator, female subjects of child bearing potential who do
             not agree to use a highly effective method of contraception.

          3. Any condition as determined by the investigator that would place a subject at an
             increased risk, or preclude subject's full compliance with the study procedures and
             visits.

          4. Female subjects who are known to be or found to be, pregnant or lactating.

          5. Subjects that are not a candidate for ESA therapies per the label warnings listed in
             the package insert for Epogen and/or contraindications to Epoetin Hospira listed in
             the Investigators' Brochure; or have had a known positive test for anti-rhEPO
             antibodies.

          6. Treatment with any investigational drug within 30 days prior to randomization and
             throughout this clinical trial.

          7. Diagnosed with any concurrent condition that could lead to greater-than-normal loss of
             blood, including but not limited to:

               -  Menorrhagia, peptic ulcer disease, gastrointestinal bleeding, blood dyscrasia,
                  hemoglobinopathy

               -  Use of anticoagulation therapy, including warfarin with a target international
                  normalized ratio (INR) of 2 or greater Anti-platelet therapy (e.g. aspirin or
                  clopidogrel) is permitted, as is heparin given during hemodialysis. Low-dose
                  warfarin is permitted and defined as the presence of at least two INR values less
                  than or equal to 1.5 during the 120 days prior to enrollment and no values
                  exceeding 1.5 at any time after 120 days prior to enrollment.

             Subjects started on warfarin with a known INR goal of 2.0 or greater are to receive no
             further treatment with the study drugs, but follow up visits can continue.

             Subjects on warfarin who meet criteria to enter the study are terminated if an INR >
             2.0 is discovered or if no INR is available for 60 days.

          8. History of transfusion of any blood product in the past 3 months, or 2 or more
             transfusions in the past 1 year; or donated or lost > 475 mL blood volume (including
             plasmapheresis) in the past 3 months.

          9. Subjects currently receiving a long acting ESA, or who have received a long acting ESA
             in the 16 weeks prior to study randomization