End stage kidney disease and anemia, treated with hemodialysis for renal replacement therapy MedDRA version: 9.1 Level: LLT Classification code 10014647 Term: End stage renal failure
Conditions
Interventions
Pharmaceutical Form: Solution for injection
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2000-
Pharmaceutical Form: Solution for injection
Concentratio
Sponsors
CONSORZIO MARIO NEGRI SUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female, age>=18, with end stage kidney disease and anemia, treated with hemodialysis for renal replacement therapy, with no contraindications to erythropoietin stimulating agents (ESA) or already treated with ESA 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: Patients with Hb levels >10 g/dl without ESA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the benefits and harms of high versus low EPOS doses for major patient-level outcomes (mortality, cardiac and cerebrovascular events, safety),quality of life and costs in a population of prevalent outpatient hemodialysis patients;Secondary Objective: xxx;Primary end point(s): composite of all-cause mortality, fatal and non fatal myocardial infarction, fatal and non fatal stroke, hospitalizations due to acute coronaric syndrome, transitory ischemich attacs, not planned coronaric revascularization, periferic revascularization. | — |
Countries
Italy
Outcome results
None listed