Effects of the dose of erythropoiesis stimulating agents on cardiac-cerebrovascular outcomes and quality of life in hemodialysis patients. The DOSe of Erythropoietins (DOSE) trial. - C.E. DOSE

• Conditions: End stage kidney disease and anemia, treated with hemodialysis for renal replacement therapy; MedDRA version: 9.1Level: LLTClassification code 10014647Term: End stage renal failure

• Registration Number: EUCTR2008-006014-20-IT
• Lead Sponsor: CONSORZIO MARIO NEGRI SUD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Patients with Hb levels >10 g/dl without ESA

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.