To prove the therapeutic equivalence of Epoetin STADA to a reference product (Erypo®) administered subcutaneously for maintaining the haemoglobin concentration in anaemic patients with end-stage renal failure on chronic haemodialysis.
Conditions
Interventions
Product Name: Epoetin STADA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Epoetin zeta
CAS Number: 604802-70-2
Concentration unit: IU international unit(s)
Concentration type: equal
Sponsors
STADA R&D GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • male or female patients, aged 18-75 years • haemodialysis patients with end-stage renal failure and renal anaemia currently on epoetin treatment for at least 3 months • patients on stable, adequate dialysis for at least three months (defined as no clinically relevant changes of dialysis regimen and/or dialyser) • informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • contraindication for the test drug • relative or absolute iron deficiency at the end of run-in period • myelodysplastic syndrome • documented bleeding disorders • platelet count below 100x109/l • known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective whether currently treated or not) • known bone marrow fibrosis (osteitis fibrosa cystica) • clinically relevant changes of dialysis regimen and/or dialyser during the trial • clinically relevant increase of CRP (higher than 10 mg/dl) for at least 2 weeks • any blood transfusion within the last 3 months prior main study phase • acute bleeding and/or recently documented haemorrhage • hypersensitivity to epoetin • epoetin dosage > 3x200 IU/kg/week • detectable anti-epoetin antibodies • uncontrolled hypertension • any of the following within the 6 months prior main study phase: - myocardial infarction, - stroke, - severe/unstable angina, - coronary/peripheral artery bypass graft, - decompensated congestive heart failure (NYHA class III – IV), - cerebrovascular incident or transient ischemic attack, - pulmonary embolism, - deep vein thrombosis, or other thromboembolic event. • known epilepsy • liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites) • patients with confirmed aluminium intoxication • confirmed, clinically relevant haemolysis and/or occult blood loss • presence of malignant tumours • clinically relevant malnutrition • pregnancy or lactation period in female patients • severe physical or mental concomitant diseases that might hamper the realisation of the trial according to protocol or the evaluation of efficacy or safety • anamnestic or current alcohol abuse i.e. consumption of more than 10 units of alcohol per week or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals 250 ml of beer, 125 ml wine or 25 ml of spirits) • participation in another clinical trial with a different test drug than the one tested in the present trial within the last 12 weeks • legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study • unreliability or lack of cooperation • lack of a possibility to attend the visits required by protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the therapeutic equivalence of Epoetin STADA to a reference product (Erypo®) administered subcutaneously for maintaining the haemoglobin concentration in anaemic patients with end-stage renal failure on chronic haemodialysis.;Secondary Objective: To gather data regarding the safety and tolerability of Epoetin STADA (with a particular focus on the formation of anti-epoetin antibodies) when administered subcutaneously.;Primary end point(s): - mean haemoglobin level during the last 4 weeks of treatment, - mean weekly epoetin dosage per kg body weight during the last 4 weeks of treatment. | — |
Countries
Bulgaria, Germany
Outcome results
None listed