Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

Launched by SANDOZ · Apr 24, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

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