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

Condition(s) targeted: Anemia; Chronic Kidney Disease (CKD)

Intervention: HX575 epoetin alfa (Drug); US-licensed epoetin alfa (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sandoz

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean absolute change in hemoglobin (Hb) levels between the screening/baseline period (week -4 to day 1) and the evaluation period (week 21 to week 28)

Secondary outcome:

Change from baseline in hemoglobin levels over time

Change from baseline in the weekly epoetin dosage (International Unit [IU] and IU/kg) over time

Incidence and severity of adverse events, and of drug related adverse events

Incidence of Antibody formation against Epoetin

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Southwestern Kidney Institute, Tempe, Arizona 85284, United States

North America Research Institute, Azusa, California 91702, United States

Central Nephrology Medical Group, Bakersfield, California 93309, United States

Pegasus Dialysis, LLC, Bakersfield, California 93308, 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

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

St Vincent Dialysis Center, Los Angeles, California 90057, United States

Tower Nephrology Medical Group, Los Angeles, California 90048, 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

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

Clinical Trial Network, Houston, Texas 77074, United States

Nephrology, P.A., Houston, Texas 77030, 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

Starting date: September 2012
Last updated: May 20, 2015