AzTrials
AzTrials

AnemiaPhase 3ACCESSNCT01693029

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

A Phase 3 study testing HX575 epoetin alfa and US-licensed epoetin alfa in people with Anemia and Chronic Kidney Disease (CKD), run by Sandoz at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Chronic Kidney Disease (CKD)
What is being tested?
HX575 epoetin alfa and US-licensed epoetin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
435 participants
Where
52 sitesUnited States
Study dates
Sep 2012to Mar 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • Mendez Center For Clinical Research, LLC

    Alexandria, Virginia, 22304

  • Research Management, Inc.

    Austin, Texas, 78756

  • North America Research Institute

    Azusa, California, 91702

  • Pegasus Dialysis, LLC

    Bakersfield, California, 93308

  • Central Nephrology Medical Group

    Bakersfield, California, 93309

  • Northeast Clinical Research Centers, Inc.

    Bethlehem, Pennsylvania, 18017

  • Metrolina Nephrology Associates, PA

    Charlotte, North Carolina, 28207

  • California Institute of Renal Research

    Chula Vista, California, 91910

  • South Florida Nephrology

    Coral Springs, Florida, 33071

  • Gamma Clinical Research Institute

    Edinburg, Texas, 78539

  • Fresenius Management Services, Inc.

    Farmington, Missouri, 63640

  • New York Hospital Queens

    Fresh Meadows, New York, 11365

  • Germantown Dialysis

    Germantown, Maryland, 20874

  • Renal Consultants Medical Group

    Granada Hills, California, 91344

  • Pines Clinical Research Inc.

    Hollywood, Florida, 33020

  • Nephrology, P.A.

    Houston, Texas, 77030

  • Clinical Trial Network

    Houston, Texas, 77074

  • Angel Kidney Care of Inglewood Dialysis Center

    Inglewood, California, 90301

  • Knoxville Kidney Center PLLC

    Knoxville, Tennessee, 37923

  • California Institute of Renal Research

    La Mesa, California, 91942

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Kidney Specialists of Southern Nevada

    Las Vegas, Nevada, 89106

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center

    Los Angeles, California, 90025

  • Tower Nephrology Medical Group

    Los Angeles, California, 90048

  • St Vincent Dialysis Center

    Los Angeles, California, 90057

  • Kidney Research Center

    Lynwood, California, 90262

  • West Virginia University Hospitals and Clinic

    Morgantown, West Virginia, 26506

  • Valley Renal Medical Group

    Northridge, California, 91324

  • Creighton University

    Omaha, Nebraska, 68131

  • Ontario Dialysis, Inc.

    Ontario, California, 91762

  • Palmetto Nephrology PA

    Orangeburg, South Carolina, 29118

  • SC Nephrology & Hypertension Center, Inc.

    Orangeburg, South Carolina, 29118

  • Four Rivers Clinical Research, Incorporated

    Paducah, Kentucky, 42003

  • Delaware Valley Nephrology and Hypertension Associates, PC

    Philadelphia, Pennsylvania, 19118

  • Seacoast Kidney and Hypertension Specialist, PLLC

    Portsmouth, New Hampshire, 03801

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Apex Research of Riverside

    Riverside, California, 92505

  • Boice-Willis Clinic, PA

    Rocky Mount, North Carolina, 27804

  • Capital Nephrology Medical Group

    Sacramento, California, 95825

  • Renal Associates, PA

    San Antonio, Texas, 78215-2035

  • California Institute of Renal Research

    San Diego, California, 92111

  • La Jolla Clinical Research, Inc.

    San Diego, California, 92154

  • North America Research Institute

    San Dimas, California, 91773

  • Northwest Louisana Nephrology

    Shreveport, Louisiana, 71101

  • Southern Utah Kidney and Hypertension Center

    St. George, Utah, 84770

  • Atekha Nephrology Clinic LLC

    Statesboro, Georgia, 30458

  • Genesis Clinical Research Corporation

    Tampa, Florida, 33614

  • Southwestern Kidney Institute

    Tempe, Arizona, 85284

  • American Institute of Research

    Whittier, California, 90603

  • Southeastern Dialysis Center

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
HX575 epoetin alfa, US-licensed epoetin alfa
Keywords
erythropoietin alfa, CKD 5d
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HX575 epoetin alfaDrug

    Also called Binocrit® (Europe), Epoetin alfa HEXAL® (Europe), Abseamed® (Europe)

    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.

  • US-licensed epoetin alfaDrug

    Also called Epogen®, Procrit®

    Solution for subcutaneous injection.

Study groups in NCT01693029
Study groupRoleWhat they receive
HX575 epoetin alfaExperimentalHX575, recombinant human epoetin alfa
Receives: Drug: HX575 epoetin alfa
US-licensed epoetin alfaActive comparatorUS-licensed recombinant human epoetin alfa
Receives: Drug: US-licensed epoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (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 .

    Measured: Week -4 to Day1 and Week 21-28

  2. Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (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 .

    Measured: Week -4 to Day1 and Week 21-28

Secondary outcomes (2)

  1. Mean Weekly Dose During Evaluation Period (Week 21-28)

    Mean weekly study drug dose during evaluation period (Week 21-28)

    Measured: Week 21-28

  2. Incidence of Antibody Formation Against Epoetin

    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.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMay 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01693029
Sponsor's protocol ID
HX575-307
Acronym
ACCESS
Status last verified
Jun 2017
First submitted
21 Sep 2012
Last updated
2 Jul 2017
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PubMed 36791280

  • Weir MR, Pergola PE, Agarwal R, Fink JC, Kopyt NP, Singh AK, Kumar J, Schmitt S, Schaffar G, Rudy A, McKay JP, Kanceva R. A Comparison of the Safety and Efficacy of HX575 (Epoetin Alfa Proposed Biosimilar) with Epoetin Alfa in Patients with End-Stage Renal Disease. Am J Nephrol. 2017;46(5):364-370. doi: 10.1159/000481736. Epub 2017 Oct 30.

    PubMed 29084409

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HX575 epoetin alfa and US-licensed epoetin alfa in people with Anemia and Chronic Kidney Disease (CKD), run by Sandoz at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01693029, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in