Status:
COMPLETED
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Lead Sponsor:
Sandoz
Collaborating Sponsors:
Hexal AG
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 Chronic Kidney Disease (CKD) subjects...
Detailed Description
This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who r...
Eligibility Criteria
Inclusion
- CKD subjects with or without dialysis treatment
- Age over 18 years
- Subjects requiring i.v. ESA treatment
- Subjects likely to remain on i.v. ESA treatment for 6 months
- Provision of informed consent -
Exclusion
- 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 aplastic 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
1695 Patients enrolled
Trial Details
Trial ID
NCT00632125
Start Date
July 1 2008
End Date
September 1 2010
Last Update
July 11 2017
Active Locations (114)
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1
Dialysepraxis Dres. Huspek/Schmid
Bad Ischl, Austria, 4820
2
Landeskrankenhaus Feldkirch
Feldkirch, Austria, 6800
3
Landeskrankenhaus Freistadt
Freistadt, Austria, 4240
4
LKH Rohrbach
Rohrbach, Austria, 4150