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

This study is currently recruiting participants.
Verified March 2013 by Sandoz
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01576341
First received: April 5, 2012
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Incidence of antibody formation against epoetin [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The incidence of antibody formation against epoetin will be tabulated with absolute and relative frequencies.


Secondary Outcome Measures:
  • Hemoglobin levels over time and change from baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Mean Hb levels as well as mean changes in Hb levels will be presented by visit.

  • Weekly epoetin dosage (IU and IU/kg) over time and change from baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The weekly epoetin dose (in total IU epoetin and in IU/kg BW) will be presented as mean time courses as well as absolute changes compared to study week 1.

  • Incidence and severity of AEs, and of drug related AEs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Incidences of treatment-emergent AEs and related AEs, treatment-emergent SAEs, and related SAEs will be summarized by MedDRA primary system organ class (SOC) and preferred term overall.


Estimated Enrollment: 360
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576341

Contacts
Contact: Sandoz Biopharmaceuticals 0049 8024 476 0

Locations
Germany
Dialysis centre Recruiting
Homberg, Hessen, Germany
Contact: Thilo Menzer, Dr. med.            
Centre for Diabetology and Nephrology Recruiting
Duesseldorf, North Rhine-Westphalia, Germany
Contact: Frank Dellanna, Prof.            
Dialysis Centre Nettetal Recruiting
Nettetal, North Rhine-Westphalia, Germany
Contact: Stefan Degenhardt, Dr. med.            
Sponsors and Collaborators
Sandoz
Investigators
Study Chair: Sandoz Biopharmaceuticals Sandoz
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01576341     History of Changes
Other Study ID Numbers: HX575-308, 2011-002871-40
Study First Received: April 5, 2012
Last Updated: March 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
 Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013