N18.5 D63.8
Conditions
Interventions
Group 1: Epoetin alfa HEXAL is applied intravenously in a dose between 1000 and 10000 I.E./injection following the instructions in Ch. 4.2 of the summary of product characteristics. The study document
Sponsors
Hexal AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Chronic haemodialysis because of terminal renal failure (CKD5). - Renal anaemia. - Therapy with prescription intravenous Epoetin alfa HEXAL under consideration of current guidelines, medical evidence and the summary of product characteristics. - Female patients: menopause completed for at least 1 years or surgically sterile or use of effective contraception. - Provided written informed consent.
Exclusion criteria
Exclusion criteria: - Known hypersensitivity vs. Epoetin alfa HEXAL or other ESA. - Solid tumour or haematological malignancy treated with cytostatic therapy. - Treatment with myelosuppressive drug. - Dependence on blood transfusions. - History of erythroblastopenia (PRCA). - Episodes of bleeding in the 30 days before admission to the study. - Orthopaedic surgery in the 30 days before admission to the study. - Diseases or complaints precluding a participation in the study, according of the study physicians judgement. - Lack of compliance. - Use of investigational medicinal products in the 30 days before admission to the study. - Women of childbearing potential not applying contraceptive measures as described above. - Breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Documentation of guidelines generally applied in the centre, treated patient populations, Hb target values in different populations, iron therapy and supervision of patients. - Documentation of demographic data, clinical status, medical history, concomitant diseases, current state of health and previous and concomitant medication (admission to study). - Documentation of dosing and treatment duration of Epoetin alfa HEXAL, therapy modifications and concomitant medications to identify Epoetin alfa HEXAL treatment schedules for renal anaemia. - Documentation of Hb target values, start of treatment depending on Hb value and adjustment of therapy; comparison with current guidelines and examination whether the management of renal anaemia changes over the study. - Documentation of dialysis dose, treatment of hyperphosphataemia and hypoalbuminaemia, restriction of interdialytic weight gain and avoidance of catheters for vascular access; comparison with the risk factors according to DOPPS and examination whether the management of renal anaemia changes over the study. - Documentation of Hb endpoints (Hb values, achievement of target values according to guidelines, Hb variability like periodic fluctuations). - Documentation of tolerability endpoints (hospital admissions, thromboembolic and vascular events, mortality). If not mentioned otherwise, these endpoints are evaluated continuously and documented at visits approximately 3, 6 and 9 months after the admission of the patients to this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Identification of different patient cohorts (clusters) with CKD5, who receive Epoetin alfa HEXAL for the treatment of renal anaemia. For this aim, data mining techniques will be used to generate patient profiles based on the above criteria. - Modelling of the above criteria at patient and physician/centre level for patients responding to treatment with Epoetin alfa HEXAL. - Modelling of the above criteria at patient and physician/centre level for patients with at least one hospital admission during therapy. - Modelling of the above criteria at patient and physician/centre level for patients with at least one thromboembolic event during therapy. - Modelling of the above criteria at patient and physician/centre level for patients who died during therapy. | — |
Countries
Germany
Contacts
Public ContactKerstin Dienes
Hexal AG
Outcome results
None listed