Phase 3
N=417
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01576341 ↗Enrolled (actual)
417
Serious AEs
24.8%
Results posted
Jun 2017
Primary outcome: Primary: Anti-Erythropoietin (EPO) Antibodies — 1.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HX575 epoetin alfa (Sandoz) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sandoz
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-Erythropoietin (EPO) Antibodies |
1.7 | — |
| SECONDARY Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) |
10.81; 10.86; 10.83; 1.61; 0.22; 1.02 | — |
Summary
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
Eligibility Criteria
Main Inclusion Criteria:
- Adult male and female patients w or w/o dialysis treatment
- Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
- Adequate iron substitution
Main Exclusion Criteria:
- History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
- Contraindications for ESA therapy
- Serum albumin < 3.0 g/dL
- Immunocompromized patients (immunosuppressive treatment, chemotherapy)
- Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
- Systemic lupus erythematosus
- Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
- History of malignancy of any organ system within the last 5 years
- History of use of any non-EU approved ESA
Data sourced from ClinicalTrials.gov (NCT01576341). 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.