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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
435

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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