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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005728-34-AT
Enrollment
1500
Registered
2008-02-18
Start date
2008-02-27
Completion date
Unknown
Last updated
2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Binocrit®,Epoetin alfa HEXAL®, Abseamed® (referred in the protocol as HX575 epoetin alfa) Product Name: HX575 epoetin alfa (registered as Binocrit®,Epoetin alfa HEXAL®, Abseamed® Product C

Sponsors

Hexal Biotech ForschungsGmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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: ;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.—

Countries

Austria, Bulgaria, France, Germany, Italy, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026