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

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ClinicalTrials.gov Identifier: NCT01576341
Recruitment Status : Completed
First Posted : April 12, 2012
Results First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Description
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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)

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: HX575 epoetin alfa (Sandoz) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients
Study Start Date : April 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HX575 epoetin alfa (Sandoz)
Single arm
 Drug: HX575 epoetin alfa (Sandoz)
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Other Name: Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®


Outcome Measures
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Primary Outcome Measures :
  1. Anti-Erythropoietin (EPO) Antibodies [ Time Frame: 52 weeks ]
    The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay


Secondary Outcome Measures :
  1. Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study) [ Time Frame: 52 weeks ]
    Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576341


Locations
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Sponsors and Collaborators
Sandoz
Investigators
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Study Chair: Sandoz Biopharmaceuticals Sandoz
More Information
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01576341    
Other Study ID Numbers: HX575-308
2011-002871-40 ( EudraCT Number )
First Posted: April 12, 2012    Key Record Dates
Results First Posted: June 19, 2017
Last Update Posted: June 19, 2017
Last Verified: April 2017
Keywords provided by Sandoz:
Epoetin alfa, ESA, HX575, CKD
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
 Renal Insufficiency
Epoetin Alfa
Hematinics