Evaluation of the Therapeutic Equivalence of Two DifferentFormulations Containing Epoetin (Epoetin STADA vs. Erypo®)Administered Subcutaneously for the Maintenance Treatmentof Renal Anaemia - Epoetin STADA s.c. vs. Erypo® s.c. as maintenance treatment of renal anemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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