Phase 3
Completed N=435
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
Anemia · Chronic Kidney Disease (CKD)
Source: ClinicalTrials.gov NCT01693029 ↗
Enrolled (actual)
435
Serious AEs
41.6%
Results posted
May 2017
Primary outcomePrimary: Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28) — -0.0960; -0.0035 g/dL
◆ Published Evidence
Established
46citations · ~15 / year
Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
Summary
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.
Linked Publications (2)
-
Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
-
A Comparison of the Safety and Efficacy of HX575 (Epoetin Alfa Proposed Biosimilar) with Epoetin Alfa in Patients with End-Stage Renal Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28) |
-0.0960; -0.0035 | — |
| PRIMARY Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28) |
10.53; 10.50; 10.42; 10.51; -0.11; 0.01 | — |
| SECONDARY Mean Weekly Dose During Evaluation Period (Week 21-28) |
5876.5; 5804.0 | — |
| SECONDARY Incidence of Antibody Formation Against Epoetin |
7; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week
- Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period
- Adequate iron substitution
Exclusion Criteria
- Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy
- History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies
- Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection
- Hepatitis C infection on an active treatment
- Symptomatic congestive heart failure (New York Heart Association [NYHA] class III and IV)
- Unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization
- Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization
- History of malignancy of any organ system
- Systemic lupus erythematous
- Immunocompromized patients
Other In-/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01693029) and the linked publication. 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. Informational only — not medical advice.