study to evaluate the efficacy and safety of hx575 hexal ag vs erypo® for the treatment of anemia in hemodialysis patients

Conditions: Anemia

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.

the primary objective of this phase iii study is the evaluation of therapeutic equivalence of hx575 hexal ag and a comparator of epoetin alfa, erypo® in the maintenance intravenous treatment of renal anemia. efficacy, dosage and safety of hx575 hexal ag in the long-term treatment were assessed.

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 \ = 5 mg/l \ =10mg/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

Keywords: treatment of anemia in hemodialysis patients