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

Anemia Clinical Trial

— ACCESS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693029
• Other study ID #: HX575-307
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2012
• Last updated: May 20, 2015
• Start date: September 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: March 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Renal Medicine Associates	Albuquerque	New Mexico
United States	Mendez Center For Clinical Research, LLC	Alexandria	Virginia
United States	Research Management, Inc.	Austin	Texas
United States	North America Research Institute	Azusa	California
United States	Central Nephrology Medical Group	Bakersfield	California
United States	Pegasus Dialysis, LLC	Bakersfield	California
United States	Northeast Clinical Research Centers, Inc.	Bethlehem	Pennsylvania
United States	Metrolina Nephrology Associates, PA	Charlotte	North Carolina
United States	California Institute of Renal Research	Chula Vista	California
United States	South Florida Nephrology	Coral Springs	Florida
United States	Gamma Clinical Research Institute	Edinburg	Texas
United States	New York Hospital Queens	Fresh Meadows	New York
United States	Germantown Dialysis	Germantown	Maryland
United States	Renal Consultants Medical Group	Granada Hills	California
United States	Pines Clinical Research Inc.	Hollywood	Florida
United States	Clinical Trial Network	Houston	Texas
United States	Nephrology, P.A.	Houston	Texas
United States	Angel Kidney Care of Inglewood Dialysis Center	Inglewood	California
United States	Knoxville Kidney Center PLLC	Knoxville	Tennessee
United States	California Institute of Renal Research	La Mesa	California
United States	Kidney Specialists of Southern Nevada	Las Vegas	Nevada
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	St Vincent Dialysis Center	Los Angeles	California
United States	Tower Nephrology Medical Group	Los Angeles	California
United States	Kidney Research Center	Lynwood	California
United States	West Virginia University Hospitals and Clinic	Morgantown	West Virginia
United States	Valley Renal Medical Group	Northridge	California
United States	Creighton University	Omaha	Nebraska
United States	Ontario Dialysis, Inc.	Ontario	California
United States	Palmetto Nephrology PA	Orangeburg	South Carolina
United States	SC Nephrology & Hypertension Center, Inc.	Orangeburg	South Carolina
United States	Four Rivers Clinical Research, Incorporated	Paducah	Kentucky
United States	Delaware Valley Nephrology and Hypertension Associates, PC	Philadelphia	Pennsylvania
United States	Seacoast Kidney and Hypertension Specialist, PLLC	Portsmouth	New Hampshire
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Apex Research of Riverside	Riverside	California
United States	Boice-Willis Clinic, PA	Rocky Mount	North Carolina
United States	Capital Nephrology Medical Group	Sacramento,	California
United States	Renal Associates, PA	San Antonio	Texas
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	Northwest Louisana Nephrology	Shreveport	Louisiana
United States	Southern Utah Kidney and Hypertension Center	St. George	Utah
United States	Atekha Nephrology Clinic LLC	Statesboro	Georgia
United States	Genesis Clinical Research Corporation	Tampa	Florida
United States	Southwestern Kidney Institute	Tempe	Arizona
United States	American Institute of Research	Whittier	California
United States	Southeastern Dialysis Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		week -4 to week 28	No
Secondary	Change from baseline in hemoglobin levels over time	Mean changes in Hb levels compared to screening/baseline will be presented by visit.	52 weeks	No
Secondary	Change from baseline in the weekly epoetin dosage (International Unit [IU] and IU/kg) over time	Absolute changes in the weekly epoetin dose (in total IU epoetin and in IU/kg body weight) compared to screening/baseline will be presented by week.	52 weeks	No
Secondary	Incidence and severity of adverse events, and of drug related adverse events	Incidences of Treatment Emergent Adverse Events (TEAEs), related TEAEs, treatment-emergent Serious Adverse Events (SAEs), and related SAEs will be summarized by the medical dictionary for regulatory activities (MedDRA) primary system organ class (SOC) and preferred term overall and, in addition, stratified by severity of the events.	52 weeks	Yes
Secondary	Incidence of Antibody formation against Epoetin	The incidence of antibody formation against epoetin will be tabulated with absolute and relative frequencies	52 weeks	No