At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,695 enrolled
Drug / intervention
HX575 recombinant human erythropoietin alfadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 4 clinical trial evaluating HX575 recombinant human erythropoietin alfa for Chronic Kidney Disease. Completed, enrolled 1,695 participants across 114 sites in 10 countries.
Detailed 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 receiving HX575 epoetin alfa i.v.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesAustria, Bulgaria, France, Germany, Italy, North Macedonia, Poland, Romania, Russia, Ukraine
CollaboratorsHexal AG
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartJul 2008
Primary CompletionMar 2010
Study CompletionSep 2010
TodayJul 2026
First PostedMar 10, 2008
Enrollment StartJul 1, 2008
Primary CompletionMar 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.3 years ago
Interventions
HX575 recombinant human erythropoietin alfadrug
HX575 epoetin alfa i.v. will be administered according to the SmPC