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

April 4, 2017 updated by: Sandoz

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany
        • Sandoz Investigative Site
      • Homberg, Germany
        • Sandoz Investigative Site
      • Nettetal, Germany
        • Sandoz Investigative Site
  • Italy
      • Bari, Italy
        • Sandoz Investigative Site
  • Poland
      • Czestochowa, Poland
        • Sandoz Investigative Site
      • Gdansk, Poland
        • Sandoz Investigative Site
      • Gdynia, Poland
        • Sandoz Investigative Site
      • Olkusz, Poland
        • Sandoz Investigative Site
      • Plock, Poland
        • Sandoz Investigative Site
      • Poznan, Poland
        • Sandoz Investigative Site
      • Wadowice, Poland
        • Sandoz Investigative Site
      • Warzawa, Poland
        • Sandoz Investigative Site
  • Romania
      • Bucuresti, Romania
        • Sandoz Investigative Site
      • Constanta, Romania
        • Sandoz Investigative Site
      • Lasi, Romania
        • Sandoz Investigative Site
      • Oradea, Romania
        • Sandoz Investigative Site
      • Timisoara, Romania
        • Sandoz Investigative Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Sandoz Investigative Site
      • Kemerovo, Russian Federation
        • Sandoz Investigative Site
      • Kolomna, Russian Federation
        • Sandoz Investigative Site
      • Moscow, Russian Federation
        • Sandoz Investigative Site
      • Mytischi, Russian Federation
        • Sandoz Investigative Site
      • Nizhny Novgorod, Russian Federation
        • Sandoz Investigative Site
      • Novosibirsk, Russian Federation
        • Sandoz Investigative Site
      • Orenburg, Russian Federation
        • Sandoz Investigative Site
      • Petrozavodsk, Russian Federation
        • Sandoz Investigative Site
      • Podolsk, Russian Federation
        • Sandoz Investigative Site
      • Pyatigorsk, Russian Federation
        • Sandoz Investigative Site
      • Ryazan, Russian Federation
        • Sandoz Investigative Site
      • Saratov, Russian Federation
        • Sandoz Investigative Site
      • Smolensk, Russian Federation
        • Sandoz Investigative Site
      • St. Petersburg, Russian Federation
        • Sandoz Investigative Site
      • Yaroslavl, Russian Federation
        • Sandoz Investigative Site
      • Yekaterinburg, Russian Federation
        • Sandoz Investigative Site
  • Turkey
      • Adana, Turkey
        • Sandoz Investigative Site
      • Ankara, Turkey
        • Sandoz Investigative Site
      • Istanbul, Turkey
        • Sandoz Investigative Site
  • Ukraine
      • Chernovtsy, Ukraine
        • Sandoz Investigative Site
      • Dnipropetrovsk, Ukraine
        • Sandoz Investigative Site
      • Donetsk, Ukraine
        • Sandoz Investigative Site
      • Ivano-Frankivsk, Ukraine
        • Sandoz Investigative Site
      • Kharkiv, Ukraine
        • Sandoz Investigative Site
      • Kyiv, Ukraine
        • Sandoz Investigative Site
      • Lugansk, Ukraine
        • Sandoz Investigative Site
      • Nikolaev, Ukraine
        • Sandoz Investigative Site
      • Poltava, Ukraine
        • Sandoz Investigative Site
      • Ternopil, Ukraine
        • Sandoz Investigative Site
      • Uzhgorod, Ukraine
        • Sandoz Investigative Site
      • Zaporizhya, Ukraine
        • Sandoz Investigative Site
      • Zhitomyr, Ukraine
        • Sandoz Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Erythropoietin (EPO) Antibodies
Time Frame: 52 weeks
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Investigators

  • Study Chair: Sandoz Biopharmaceuticals, Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (ESTIMATE)

April 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX575-308
  • 2011-002871-40 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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