Post-authorization safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human erythropoietin alfa i.v. - ND

• Conditions: Chronic kidney disease subjects with or without dialysis treatment and requiring i.v. ESA treatment; MedDRA version: 9.1Level: LLTClassification code 10009120Term: Chronic renal failure anaemia

• Registration Number: EUCTR2007-005728-34-IT
• Lead Sponsor: HEXAL BIOTECH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-21
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

CKD subjects with or without dialysis treatment Age > or ═ 18 years Subjects requiring i.v. ESA treatment Subjects likely to remain on i.v. ESA treatment equal or more than 6 months Provision of informed consent
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

Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product History of PRCA or aplasic anemia History of anti-erythropoietin antibodies Uncontrolled hypertension Pregnant woman or nursing mother Women of childbearing potential do not agree to maintain effective birth control during the study treatment period.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 epoetin alfa i.v;Secondary Objective: N/A;Primary end point(s): Determination of relevant drug-related adverse events and EPO-related lack of efficacy incidence among CKD subjects receiving HX575 epoetin alfa i.v.