Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
ACCESS
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
1 other identifier
interventional
435
1 country
52
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2012
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 21, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
May 12, 2017
CompletedJuly 2, 2017
June 1, 2017
1.7 years
September 21, 2012
April 4, 2017
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 .
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)
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 Outcomes (2)
Mean Weekly Dose During Evaluation Period (Week 21-28)
Week 21-28
Incidence of Antibody Formation Against Epoetin
52 weeks
Study Arms (2)
HX575 epoetin alfa
EXPERIMENTALHX575, recombinant human epoetin alfa
US-licensed epoetin alfa
ACTIVE COMPARATORUS-licensed recombinant human epoetin alfa
Interventions
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.
Solution for subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (52)
Southwestern Kidney Institute
Tempe, Arizona, 85284, United States
North America Research Institute
Azusa, California, 91702, United States
Pegasus Dialysis, LLC
Bakersfield, California, 93308, United States
Central Nephrology Medical Group
Bakersfield, California, 93309, United States
California Institute of Renal Research
Chula Vista, California, 91910, United States
Renal Consultants Medical Group
Granada Hills, California, 91344, United States
Angel Kidney Care of Inglewood Dialysis Center
Inglewood, California, 90301, United States
California Institute of Renal Research
La Mesa, California, 91942, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center
Los Angeles, California, 90025, United States
Tower Nephrology Medical Group
Los Angeles, California, 90048, United States
St Vincent Dialysis Center
Los Angeles, California, 90057, United States
Kidney Research Center
Lynwood, California, 90262, United States
Valley Renal Medical Group
Northridge, California, 91324, United States
Ontario Dialysis, Inc.
Ontario, California, 91762, United States
Apex Research of Riverside
Riverside, California, 92505, United States
Capital Nephrology Medical Group
Sacramento, California, 95825, United States
California Institute of Renal Research
San Diego, California, 92111, United States
La Jolla Clinical Research, Inc.
San Diego, California, 92154, United States
North America Research Institute
San Dimas, California, 91773, United States
American Institute of Research
Whittier, California, 90603, United States
South Florida Nephrology
Coral Springs, Florida, 33071, United States
Pines Clinical Research Inc.
Hollywood, Florida, 33020, United States
Genesis Clinical Research Corporation
Tampa, Florida, 33614, United States
Atekha Nephrology Clinic LLC
Statesboro, Georgia, 30458, United States
Four Rivers Clinical Research, Incorporated
Paducah, Kentucky, 42003, United States
Northwest Louisana Nephrology
Shreveport, Louisiana, 71101, United States
Germantown Dialysis
Germantown, Maryland, 20874, United States
Fresenius Management Services, Inc.
Farmington, Missouri, 63640, United States
Creighton University
Omaha, Nebraska, 68131, United States
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89106, United States
Seacoast Kidney and Hypertension Specialist, PLLC
Portsmouth, New Hampshire, 03801, United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109, United States
New York Hospital Queens
Fresh Meadows, New York, 11365, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28207, United States
Boice-Willis Clinic, PA
Rocky Mount, North Carolina, 27804, United States
Southeastern Dialysis Center
Wilmington, North Carolina, 28401, United States
Northeast Clinical Research Centers, Inc.
Bethlehem, Pennsylvania, 18017, United States
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, 19118, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Palmetto Nephrology PA
Orangeburg, South Carolina, 29118, United States
SC Nephrology & Hypertension Center, Inc.
Orangeburg, South Carolina, 29118, United States
Knoxville Kidney Center PLLC
Knoxville, Tennessee, 37923, United States
Research Management, Inc.
Austin, Texas, 78756, United States
Gamma Clinical Research Institute
Edinburg, Texas, 78539, United States
Nephrology, P.A.
Houston, Texas, 77030, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Renal Associates, PA
San Antonio, Texas, 78215-2035, United States
Southern Utah Kidney and Hypertension Center
St. George, Utah, 84770, United States
Mendez Center For Clinical Research, LLC
Alexandria, Virginia, 22304, United States
West Virginia University Hospitals and Clinic
Morgantown, West Virginia, 26506, United States
Related Publications (2)
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.
PMID: 36791280DERIVEDWeir 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.
PMID: 29084409DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biopharmaceutical Clinical Development, Strategic Planning
- Organization
- Sandoz
Study Officials
- STUDY DIRECTOR
Sandoz Biopharmaceutical Clinical Development
Sandoz Biopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2012
First Posted
September 26, 2012
Study Start
September 1, 2012
Primary Completion
May 1, 2014
Study Completion
March 1, 2015
Last Updated
July 2, 2017
Results First Posted
May 12, 2017
Record last verified: 2017-06