randomized, controlled, double-blind multicenter safety study to evaluate the safety and immunogenicity of subcutaneous epo hexal vs. erypo® in the treatment of anemia associated with chronic renal insufficiency in predialysis patients

Conditions: Anemia; Chronic Renal Insufficiency

Summary: this is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia. symptomatic anemia will be corrected by s.c. application of epo hexal or erypo® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dl.


Eligibility criteria:
inclusion criteria: * known chronic renal insufficiency of at least 4 weeks duration; ckd stage at least 3 or higher * male and female patients, age: \>=18 * patients who are naïve to esa treatment or previously esa treated after 3 months of esa-free period (i.v. or s.c.) * patients with symptomatic anemia, defined as hb level below 11.0 g/dl and not lower than or equal to 7.5 g/dl on at least 2 visits during the screening period * adequate iron status, serum ferritin \>= 100 µg/l or transferrin saturation \>= 20% * ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration * written informed consent of the patient. exclusion criteria: * anemia of non-renal causes * therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis) * patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis) * patients with acute deterioration of renal function during the screening phase according to the investigator's judgment * patients receiving any rbc/whole blood transfusion during the screening period * primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia) * evidence of uncontrolled diabetes mellitus (hba1c \> 10 % at visit -2) * evidence of severe hepatic dysfunction (e.g. alt and/or ast above 2x upper limit of normal range; or gamma-gt above 3x upper limit of normal range) * clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone \> 500 ng/l at visit -2. * uncontrolled hypertension, defined as a systolic blood pressure of \>= 160 mmhg and a diastolic blood pressure measurement \>= 100 mmhg (average of two values with at least one day between measurements) * congestive heart failure and/or angina pectoris \[new york heart association (nyha) class iii and iv\] * history of stroke or myocardial infarction during the last 6 months prior to visit -2 * ongoing treatment with phenprocoumon or other cumarin derivates * thrombocytopenia (platelet count \<100.000/µl) or leucopenia (white blood cell count \< 2.000/µl) * gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis * evidence of acute or chronic infection by a c-reactive protein value of \> 30 mg/l * suspicion or known prca (pure red cell aplasia) * previously diagnosed hiv or acute hepatitis infection * history of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening * planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery) * clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer) * pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, iud, sexual abstinence, vasectomised partner) * known history of severe drug related allergies (e.g. anaphylactic shock) * known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products * known or suspicion of any non-compliance with respect to subcutaneous treatment * simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study * participation in another esa study in the 3 months preceding 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 associated with cri