A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Condition: Chronic Renal Failure; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Intervention: Epoetin Hospira; Epogen Amgen
Intervention description: Variable dose; Variable dose
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC)
      Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels
      and study drug dose requirements in patients treated for anemia associated with chronic renal
      failure and on hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is able to provide written informed consent after risks and benefits of the
             study have been explained prior to any study related activities

          2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable
             Epogen (Amgen) dose administered IV or SC, 1 to 3 times per week for whom the
             following apply:

               -  A change in Epogen dosing of no more than 10% from the mean

               -  Mean hemoglobin between 9.0 and 11.0 g/dL

               -  No more than one hemoglobin result outside of range from 9.0-11.0 g/dL

               -  No hemoglobin result more than ±1 g/dL from the mean hemoglobin level

          3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization,
             defined as no clinically relevant changes of dialysis regimen and/or dialyzer

          4. Patients with adequate iron stores, defined as plasma ferritin > 100 μg/L and TSAT
             >20%, prior to randomization

          5. Male or female patients aged 18 to 80 years (both inclusive)

          6. If female, patient must be postmenopausal for at least one year prior to
             randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
             hysterectomy), or practicing at least one of the following methods of birth control:

               -  hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months
                  prior to randomization

               -  intrauterine device (IUD)

               -  double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring
                  with spermicidal jellies or cream)

        If hormonal contraceptives are used, the specific contraceptive must have been used for at
        least 3 months prior to randomization. If the patient is currently using a hormonal
        contraceptive, she should also use a barrier method during this study and for at least 30
        days following the administration of the patient's last dose

        Exclusion Criteria:

          1. Maintenance epoetin dosage >600 U/kg per week (1-3 times per week)

          2. Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior
             to randomization

          3. Any of the following within 3 months prior to randomization:

               -  Myocardial infarction

               -  Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or
                  transient ischemic attack/intracerebral bleeding/cerebral infarction

               -  Severe/unstable angina

               -  Coronary angioplasty, bypass surgery, or peripheral artery bypass graft

               -  Decompensated congestive heart failure (New York Heart Association [NYHA] class
                  IV)

               -  Pulmonary embolism

               -  Deep vein thrombosis or other thromboembolic event

               -  Received live or attenuated vaccination (except flu vaccination)

          4. Uncontrolled hypertension within the 4 weeks prior to randomization defined as more
             than 10% of post-dialysis blood pressures >170 mmHg systolic and/or >110 mmHg
             diastolic, based on blood pressure readings obtained when the patient's post-dialysis
             body weight was not more than 0.5 kg above their listed dry weight

          5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective
             of whether currently treated or not)

          6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease
             that in the Investigator's opinion may be significant to exclude participation in the
             study, including but not limited to demyelinating diseases such as multiple sclerosis,
             microbial, viral or fungal infection or mental disease

          7. Contraindication for the test drug or have been previously treated with Epoetin
             Hospira

          8. Relative or absolute iron deficiency prior to randomization into the Maintenance
             Period

          9. Platelet count below 100 x 10^9/L

         10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks

         11. Significant drug sensitivity or a significant allergic reaction to any drug, as well
             as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients,
             including albumin) or any other related drugs that in the judgment of the Investigator
             is exclusionary for the study participation

         12. History of any of the following:

               -  Detectable anti-rhEPO antibodies

               -  Clinically relevant malnutrition

               -  Confirmed aluminum intoxication

               -  Myelodysplastic syndrome

               -  Known bone marrow fibrosis (osteitis fibrosa cystica)

               -  Known seizure disorder

               -  Liver cirrhosis with clinical evidence of complications (portal hypertension,
                  splenomegaly, ascites)

         13. A female patient who is pregnant, lactating or planning a pregnancy during the study

         14. History of drug abuse or alcohol abuse within 2 years prior to randomization as
             determined by the Investigator

         15. Current participation or participation in a drug or other investigational research
             study within 30 days prior to randomization

         16. May not be able to comply with the requirements of this clinical study, communicate
             effectively with study personnel, or is considered by the Investigator, for any
             reason, to be an unsuitable candidate for the study

         17. Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had
             a transfusion of any blood product within 3 months prior to randomization

         18. A patient who in the Investigator's opinion, has any clinically significant abnormal
             laboratory evaluations, including liver function taken at Screening Visit

         19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface
             antigen (HBsAg)