Post authorisation 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. - not applicable

Phase 1

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

• Registration Number: EUCTR2007-005728-34-GB
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-15
• Study Completion: 2010-02-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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