Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa (ACCESS)

June 1, 2017 updated by: Sandoz

Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease (CKD).

Study Type

Interventional

Enrollment (Actual)

435

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

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Southwestern Kidney Institute
    • California
      • Azusa, California, United States, 91702
        • North America Research Institute
      • Bakersfield, California, United States, 93308
        • Pegasus Dialysis, LLC
      • Bakersfield, California, United States, 93309
        • Central Nephrology Medical Group
      • Chula Vista, California, United States, 91910
        • California Institute of Renal Research
      • Granada Hills, California, United States, 91344
        • Renal Consultants Medical Group
      • Inglewood, California, United States, 90301
        • Angel Kidney Care of Inglewood Dialysis Center
      • La Mesa, California, United States, 91942
        • California Institute of Renal Research
      • Laguna Hills, California, United States, 92653
        • Alliance Research Centers
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Los Angeles, California, United States, 90048
        • Tower Nephrology Medical Group
      • Los Angeles, California, United States, 90025
        • Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center
      • Los Angeles, California, United States, 90057
        • St Vincent Dialysis Center
      • Lynwood, California, United States, 90262
        • Kidney Research Center
      • Northridge, California, United States, 91324
        • Valley Renal Medical Group
      • Ontario, California, United States, 91762
        • Ontario Dialysis, Inc.
      • Riverside, California, United States, 92505
        • Apex Research of Riverside
      • Sacramento, California, United States, 95825
        • Capital Nephrology Medical Group
      • San Diego, California, United States, 92111
        • California Institute of Renal Research
      • San Diego, California, United States, 92154
        • La Jolla Clinical Research, Inc.
      • San Dimas, California, United States, 91773
        • North America Research Institute
      • Whittier, California, United States, 90603
        • American Institute of Research
    • Florida
      • Coral Springs, Florida, United States, 33071
        • South Florida Nephrology
      • Hollywood, Florida, United States, 33020
        • Pines Clinical Research Inc.
      • Tampa, Florida, United States, 33614
        • Genesis Clinical Research Corporation
    • Georgia
      • Statesboro, Georgia, United States, 30458
        • Atekha Nephrology Clinic LLC
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research, Incorporated
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Northwest Louisana Nephrology
    • Maryland
      • Germantown, Maryland, United States, 20874
        • Germantown Dialysis
    • Missouri
      • Farmington, Missouri, United States, 63640
        • Fresenius Management Services, Inc.
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Kidney Specialists of Southern Nevada
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Seacoast Kidney and Hypertension Specialist, PLLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Renal Medicine Associates
    • New York
      • Fresh Meadows, New York, United States, 11365
        • New York Hospital Queens
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Metrolina Nephrology Associates, PA
      • Rocky Mount, North Carolina, United States, 27804
        • Boice-Willis Clinic, PA
      • Wilmington, North Carolina, United States, 28401
        • Southeastern Dialysis Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Northeast Clinical Research Centers, Inc.
      • Philadelphia, Pennsylvania, United States, 19118
        • Delaware Valley Nephrology and Hypertension Associates, PC
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • SC Nephrology & Hypertension Center, Inc.
      • Orangeburg, South Carolina, United States, 29118
        • Palmetto Nephrology Pa
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center PLLC
    • Texas
      • Austin, Texas, United States, 78756
        • Research Management, Inc.
      • Edinburg, Texas, United States, 78539
        • Gamma Clinical Research Institute
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77030
        • Nephrology, P.A.
      • San Antonio, Texas, United States, 78215-2035
        • Renal Associates, PA
    • Utah
      • Saint George, Utah, United States, 84770
        • Southern Utah Kidney and Hypertension Center
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Mendez Center for Clinical Research, LLC
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals and Clinic

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

Inclusion Criteria:

  • Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week
  • Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period
  • Adequate iron substitution

Exclusion Criteria:

  • Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy
  • History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies
  • Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection
  • Hepatitis C infection on an active treatment
  • Symptomatic congestive heart failure (New York Heart Association [NYHA] class III and IV)
  • Unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization
  • Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization
  • History of malignancy of any organ system
  • Systemic lupus erythematous
  • Immunocompromized patients

Other In-/Exclusion criteria may apply

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HX575 epoetin alfa
HX575, recombinant human epoetin alfa
Drug: HX575 epoetin alfa
Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.
Other Names:
  • Binocrit® (Europe)
  • Epoetin alfa HEXAL® (Europe)
  • Abseamed® (Europe)
Active Comparator: US-licensed epoetin alfa
US-licensed recombinant human epoetin alfa
Drug: US-licensed epoetin alfa
Solution for subcutaneous injection.
Other Names:
  • Epogen®
  • Procrit®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)
Time Frame: Week -4 to Day1 and Week 21-28
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
Week -4 to Day1 and Week 21-28
Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)
Time Frame: Week -4 to Day1 and Week 21-28
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
Week -4 to Day1 and Week 21-28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Weekly Dose During Evaluation Period (Week 21-28)
Time Frame: Week 21-28
Mean weekly study drug dose during evaluation period (Week 21-28)
Week 21-28
Incidence of Antibody Formation Against Epoetin
Time Frame: 52 weeks
Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.
52 weeks

Collaborators and Investigators

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

Sponsor

Sandoz

Investigators

  • Study Director: Sandoz Biopharmaceutical Clinical Development, Sandoz Biopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX575-307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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