Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
Condition: Anemia
MeSH terms: Anemia
Intervention: HX575 epoetin alfa Hexal AG; ERYPO®, Janssen-Cilag
Intervention description: HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin; Solution for i.v. injection
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of anemia in hemodialysis patients

Summary:

      This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving
      about 462 clinically stable hemodialysis patients aged 18 years or above suffering from
      anemia and treated previously with a stable dose of ERYPO® intravenously.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving dialysis for at least 6 months (3 times weekly) before screening

          -  Age: >=18

          -  Clinically stable, i.e. hemoglobin within the established range (10.0 to 13.0 g/dl)
             for at least 12 weeks before screening

          -  Stable intravenous dosage of ERYPO® three times weekly for at least 8 weeks before
             screening and during screening with a maximal weekly dosage of 300 IU/kg body weight
             (stable is defined as <25% change (up or down) in weekly dose and no change in
             frequency over 8 weeks prior screening and 10 weeks prior randomisation)

          -  Baseline hemoglobin concentration of 10.0 to 13.0 g/dl (mean of two pre-randomization
             pre-dialysis samples of Hb at visit -2 and visit 1)

          -  Serum ferritin >=100 µg/l and/or saturated transferrin levels >=20%

          -  C-reactive protein <15 mg/l (< 5 mg/l: normal; >= 5 mg/l < 10 mg/l: +; >=10mg/l < 100
             mg/l: ++; >=100 mg/l: +++)

          -  Ability to follow study instructions and likely to complete all required visits

          -  Written informed consent of the patient

        Exclusion Criteria:

          -  Anemia of non-renal causes

          -  Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia,
             hematological malignancy, hemolytic anemia)

          -  Evidence of severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal
             range; or gamma-GT above 3 x upper limit of normal range)

          -  Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid
             hormone >1500 pg/mL).

          -  Known history of bone marrow disease

          -  Any red blood cell transfusion(s) during the last 12 weeks before screening or during
             the screening/baseline period

          -  Insufficient concomitant iron treatment during the last 2 months before Visit -2

          -  Uncontrolled hypertension, defined as a predialysis diastolic blood pressure
             measurement >=110 mmHg during the screening period

          -  Congestive heart failure [New York Heart Association (NYHA) class III and IV]

          -  Unstable angina pectoris, active cardiac disease, cardiac infarction during the last
             six months before screening

          -  History of blood coagulation disease

          -  Thrombocytopenia (platelet count <100.000/µl)

          -  Leukopenia (white blood cell count < 2.000/µl)

          -  Overt bleeding (acute or chronic bleeding within 2 months of inclusion) or hemolysis

          -  Evidence of acute infectious disease or serious active inflammatory states within one
             months before screening (Visit -2) or during the screening/baseline period

          -  Suspicion or known PRCA (pure red cell aplasia)

          -  Previously diagnosed HIV or acute hepatitis infection

          -  Treatment for epilepsy within the past 6 months

          -  Planned surgery during the next 7 months (except vascular access surgery)

          -  Any androgen therapy within 2 months before visit -2 and during the study

          -  Therapy with immunosuppressants or any drug known to affect the hematocrit within 1
             month before Visit -2 and during the study

          -  Clinical evidence of malignant diseases

          -  Pregnancy, breastfeeding women or women not using adequate birth control measures

          -  Known history of severe drug related allergies

          -  Known allergy to one of the ingredients of the test or reference products or
             hypersensitivity to mammalian-derived products

          -  Simultaneous participation in another clinical study or participation in a study in
             the month preceding the start of this study or previously randomized in this study

          -  Participation in an erythropoietin study in the 3 months preceding screening (visit
             -2)

          -  Any other condition which at the investigator´s discretion may put the patient at risk
             or which may confound the study results