HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: HX575 epoetin alfa (Sandoz)

• Registration Number: NCT01576341
• Lead Sponsor: Sandoz

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Primary Completion: 2014-10
• Study Completion: 2015-06
• Status Verified: 2017-04
• Results First Submitted: 2017-04-03
• Results First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Results First Posted: 2017-06-19
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HX575 epoetin alfa (Sandoz)	HX575 epoetin alfa (Sandoz)	Single arm

Primary Outcome Measures

Name	Time	Method
Anti-Erythropoietin (EPO) Antibodies	52 weeks	The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)	52 weeks	Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)

Trial Locations

Locations (1)

Sandoz Investigative Site; 🇺🇦 Zhitomyr, Ukraine

Sandoz Investigative Site

🇺🇦Zhitomyr, Ukraine