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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Collaborator: Hexal AG
• Treatments: Epoetin Alfa; Pharmaceutical Solutions

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