Phase 4
N=1,695
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00632125 ↗Enrolled (actual)
1,695
Serious AEs
26.9%
Results posted
Jul 2017
Primary outcome: Primary: Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects — 7; 0.18 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HX575 recombinant human erythropoietin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sandoz
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects |
7; 0.18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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 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.
Data sourced from ClinicalTrials.gov (NCT00632125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.