Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
NCT ID: NCT01693029
Last Updated: 2017-07-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
435 participants
INTERVENTIONAL
2012-09-30
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
NCT01628120
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
NCT01473420
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
NCT01576341
Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients
NCT03408639
A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
NCT02504294
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HX575 epoetin alfa
HX575, recombinant human epoetin alfa
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.
US-licensed epoetin alfa
US-licensed recombinant human epoetin alfa
US-licensed epoetin alfa
Solution for subcutaneous injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
US-licensed epoetin alfa
Solution for subcutaneous injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period
* Adequate iron substitution
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sandoz
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sandoz Biopharmaceutical Clinical Development
Role: STUDY_DIRECTOR
Sandoz Biopharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Trial Network
Houston, Texas, United States
Knoxville Kidney Center PLLC
Knoxville, Tennessee, United States
Research Management, Inc.
Austin, Texas, United States
Gamma Clinical Research Institute
Edinburg, Texas, United States
Nephrology, P.A.
Houston, Texas, United States
Southwestern Kidney Institute
Tempe, Arizona, United States
North America Research Institute
Azusa, California, United States
Pegasus Dialysis, LLC
Bakersfield, California, United States
Central Nephrology Medical Group
Bakersfield, California, United States
California Institute of Renal Research
Chula Vista, California, United States
Renal Consultants Medical Group
Granada Hills, California, United States
Angel Kidney Care of Inglewood Dialysis Center
Inglewood, California, United States
California Institute of Renal Research
La Mesa, California, United States
Alliance Research Centers
Laguna Hills, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center
Los Angeles, California, United States
Tower Nephrology Medical Group
Los Angeles, California, United States
St Vincent Dialysis Center
Los Angeles, California, United States
Kidney Research Center
Lynwood, California, United States
Valley Renal Medical Group
Northridge, California, United States
Ontario Dialysis, Inc.
Ontario, California, United States
Apex Research of Riverside
Riverside, California, United States
Capital Nephrology Medical Group
Sacramento, California, United States
California Institute of Renal Research
San Diego, California, United States
La Jolla Clinical Research, Inc.
San Diego, California, United States
North America Research Institute
San Dimas, California, United States
American Institute of Research
Whittier, California, United States
South Florida Nephrology
Coral Springs, Florida, United States
Pines Clinical Research Inc.
Hollywood, Florida, United States
Genesis Clinical Research Corporation
Tampa, Florida, United States
Atekha Nephrology Clinic LLC
Statesboro, Georgia, United States
Four Rivers Clinical Research, Incorporated
Paducah, Kentucky, United States
Northwest Louisana Nephrology
Shreveport, Louisiana, United States
Germantown Dialysis
Germantown, Maryland, United States
Fresenius Management Services, Inc.
Farmington, Missouri, United States
Creighton University
Omaha, Nebraska, United States
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, United States
Seacoast Kidney and Hypertension Specialist, PLLC
Portsmouth, New Hampshire, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
New York Hospital Queens
Fresh Meadows, New York, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Boice-Willis Clinic, PA
Rocky Mount, North Carolina, United States
Southeastern Dialysis Center
Wilmington, North Carolina, United States
Northeast Clinical Research Centers, Inc.
Bethlehem, Pennsylvania, United States
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Palmetto Nephrology PA
Orangeburg, South Carolina, United States
SC Nephrology & Hypertension Center, Inc.
Orangeburg, South Carolina, United States
Renal Associates, PA
San Antonio, Texas, United States
Southern Utah Kidney and Hypertension Center
St. George, Utah, United States
Mendez Center For Clinical Research, LLC
Alexandria, Virginia, United States
West Virginia University Hospitals and Clinic
Morgantown, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HX575-307
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.