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Completed

NCT Number: NCT01576341

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

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)

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sandoz Investigative Site, Düsseldorf, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HX575 epoetin alfa (Sandoz)

Drug

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 names: Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®

Primary outcomes

  1. Anti-Erythropoietin (EPO) Antibodies

    Time frame: 52 weeks

    The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study 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

Acronym: SENSE

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 12, 2012
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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