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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01576341
First received: April 5, 2012
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Chronic Kidney Disease Drug: HX575 epoetin alfa (Sandoz) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Sandoz:

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


Secondary Outcome Measures:
  • 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)


Enrollment: 417
Study Start Date: April 2012
Study Completion Date: June 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576341

  Show 50 Study Locations
Sponsors and Collaborators
Sandoz
Investigators
Study Chair: Sandoz Biopharmaceuticals Sandoz
  More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01576341     History of Changes
Other Study ID Numbers: HX575-308
2011-002871-40 ( EudraCT Number )
Study First Received: April 5, 2012
Results First Received: April 3, 2017
Last Updated: April 4, 2017

Keywords provided by Sandoz:
Epoetin alfa, ESA, HX575, CKD

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on June 22, 2017