Clinical trial NCT01693029: Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Chronic Kidney Disease (CKD)
Keywords: erythropoietin alfa
CKD 5d
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)
timeFrame: Week -4 to Day1 and Week 21-28
measure: Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)
timeFrame: Week -4 to Day1 and Week 21-28
Secondary outcomes:
measure: Mean Weekly Dose During Evaluation Period (Week 21-28)
timeFrame: Week 21-28
measure: Incidence of Antibody Formation Against Epoetin
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Southwestern Kidney Institute
state: Arizona
city: Azusa
country: United States
facility: North America Research Institute
state: California
city: Bakersfield
country: United States
facility: Pegasus Dialysis, LLC
state: California
city: Bakersfield
country: United States
facility: Central Nephrology Medical Group
state: California
city: Chula Vista
country: United States
facility: California Institute of Renal Research
state: California
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group
state: California
city: Inglewood
country: United States
facility: Angel Kidney Care of Inglewood Dialysis Center
state: California
city: La Mesa
country: United States
facility: California Institute of Renal Research
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center
state: California
city: Los Angeles
country: United States
facility: Tower Nephrology Medical Group
state: California
city: Los Angeles
country: United States
facility: St Vincent Dialysis Center
state: California
city: Lynwood
country: United States
facility: Kidney Research Center
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group
state: California
city: Ontario
country: United States
facility: Ontario Dialysis, Inc.
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: Sacramento
country: United States
facility: Capital Nephrology Medical Group
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: San Diego
country: United States
facility: La Jolla Clinical Research, Inc.
state: California
city: San Dimas
country: United States
facility: North America Research Institute
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Coral Springs
country: United States
facility: South Florida Nephrology
state: Florida
city: Hollywood
country: United States
facility: Pines Clinical Research Inc.
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research Corporation
state: Florida
city: Statesboro
country: United States
facility: Atekha Nephrology Clinic LLC
state: Georgia
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Incorporated
state: Kentucky
city: Shreveport
country: United States
facility: Northwest Louisana Nephrology
state: Louisiana
city: Germantown
country: United States
facility: Germantown Dialysis
state: Maryland
city: Farmington
country: United States
facility: Fresenius Management Services, Inc.
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Las Vegas
country: United States
facility: Kidney Specialists of Southern Nevada
state: Nevada
city: Portsmouth
country: United States
facility: Seacoast Kidney and Hypertension Specialist, PLLC
state: New Hampshire
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: Fresh Meadows
country: United States
facility: New York Hospital Queens
state: New York
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates, PA
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic, PA
state: North Carolina
city: Wilmington
country: United States
facility: Southeastern Dialysis Center
state: North Carolina
city: Bethlehem
country: United States
facility: Northeast Clinical Research Centers, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Delaware Valley Nephrology and Hypertension Associates, PC
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Orangeburg
country: United States
facility: Palmetto Nephrology PA
state: South Carolina
city: Orangeburg
country: United States
facility: SC Nephrology & Hypertension Center, Inc.
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville Kidney Center PLLC
state: Tennessee
city: Austin
country: United States
facility: Research Management, Inc.
state: Texas
city: Edinburg
country: United States
facility: Gamma Clinical Research Institute
state: Texas
city: Houston
country: United States
facility: Nephrology, P.A.
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Renal Associates, PA
state: Texas
city: Saint George
country: United States
facility: Southern Utah Kidney and Hypertension Center
state: Utah
city: Alexandria
country: United States
facility: Mendez Center For Clinical Research, LLC
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospitals and Clinic
state: West Virginia
Study officials:
affiliation: Sandoz Biopharmaceuticals
name: Sandoz Biopharmaceutical Clinical Development
role: STUDY_DIRECTOR
References:
citation: 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.