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

Primary Purpose

Anemia, Chronic Kidney Disease (CKD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HX575 epoetin alfa
US-licensed epoetin alfa
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring erythropoietin alfa, CKD 5d

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwestern Kidney Institute
  • North America Research Institute
  • Pegasus Dialysis, LLC
  • Central Nephrology Medical Group
  • California Institute of Renal Research
  • Renal Consultants Medical Group
  • Angel Kidney Care of Inglewood Dialysis Center
  • California Institute of Renal Research
  • Alliance Research Centers
  • Academic Medical Research Institute
  • Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center
  • Tower Nephrology Medical Group
  • St Vincent Dialysis Center
  • Kidney Research Center
  • Valley Renal Medical Group
  • Ontario Dialysis, Inc.
  • Apex Research of Riverside
  • Capital Nephrology Medical Group
  • California Institute of Renal Research
  • La Jolla Clinical Research, Inc.
  • North America Research Institute
  • American Institute of Research
  • South Florida Nephrology
  • Pines Clinical Research Inc.
  • Genesis Clinical Research Corporation
  • Atekha Nephrology Clinic LLC
  • Four Rivers Clinical Research, Incorporated
  • Northwest Louisana Nephrology
  • Germantown Dialysis
  • Fresenius Management Services, Inc.
  • Creighton University
  • Kidney Specialists of Southern Nevada
  • Seacoast Kidney and Hypertension Specialist, PLLC
  • Renal Medicine Associates
  • New York Hospital Queens
  • Metrolina Nephrology Associates, PA
  • Boice-Willis Clinic, PA
  • Southeastern Dialysis Center
  • Northeast Clinical Research Centers, Inc.
  • Delaware Valley Nephrology and Hypertension Associates, PC
  • Rhode Island Hospital
  • Palmetto Nephrology PA
  • SC Nephrology & Hypertension Center, Inc.
  • Knoxville Kidney Center PLLC
  • Research Management, Inc.
  • Gamma Clinical Research Institute
  • Nephrology, P.A.
  • Clinical Trial Network
  • Renal Associates, PA
  • Southern Utah Kidney and Hypertension Center
  • Mendez Center For Clinical Research, LLC
  • West Virginia University Hospitals and Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HX575 epoetin alfa

US-licensed epoetin alfa

Arm Description

HX575, recombinant human epoetin alfa

US-licensed recombinant human epoetin alfa

Outcomes

Primary Outcome Measures

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 .
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 .

Secondary Outcome Measures

Mean Weekly Dose During Evaluation Period (Week 21-28)
Mean weekly study drug dose during evaluation period (Week 21-28)
Incidence of Antibody Formation Against Epoetin
Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.

Full Information

First Posted
September 21, 2012
Last Updated
June 1, 2017
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT01693029
Brief Title
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease (CKD)
Keywords
erythropoietin alfa, CKD 5d

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
435 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HX575 epoetin alfa
Arm Type
Experimental
Arm Description
HX575, recombinant human epoetin alfa
Arm Title
US-licensed epoetin alfa
Arm Type
Active Comparator
Arm Description
US-licensed recombinant human epoetin alfa
Intervention Type
Drug
Intervention Name(s)
HX575 epoetin alfa
Other Intervention Name(s)
Binocrit® (Europe), Epoetin alfa HEXAL® (Europe), Abseamed® (Europe)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
US-licensed epoetin alfa
Other Intervention Name(s)
Epogen®, Procrit®
Intervention Description
Solution for subcutaneous injection.
Primary Outcome Measure Information:
Title
Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)
Description
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 .
Time Frame
Week -4 to Day1 and Week 21-28
Title
Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)
Description
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 .
Time Frame
Week -4 to Day1 and Week 21-28
Secondary Outcome Measure Information:
Title
Mean Weekly Dose During Evaluation Period (Week 21-28)
Description
Mean weekly study drug dose during evaluation period (Week 21-28)
Time Frame
Week 21-28
Title
Incidence of Antibody Formation Against Epoetin
Description
Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz Biopharmaceutical Clinical Development
Organizational Affiliation
Sandoz Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Southwestern Kidney Institute
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
North America Research Institute
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Pegasus Dialysis, LLC
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
Central Nephrology Medical Group
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
California Institute of Renal Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Renal Consultants Medical Group
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Angel Kidney Care of Inglewood Dialysis Center
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
California Institute of Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Alliance Research Centers
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Tower Nephrology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
St Vincent Dialysis Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Kidney Research Center
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Valley Renal Medical Group
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Ontario Dialysis, Inc.
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Capital Nephrology Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
La Jolla Clinical Research, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
North America Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
South Florida Nephrology
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Pines Clinical Research Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
Genesis Clinical Research Corporation
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Atekha Nephrology Clinic LLC
City
Statesboro
State/Province
Georgia
ZIP/Postal Code
30458
Country
United States
Facility Name
Four Rivers Clinical Research, Incorporated
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Northwest Louisana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Germantown Dialysis
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20874
Country
United States
Facility Name
Fresenius Management Services, Inc.
City
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Kidney Specialists of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Seacoast Kidney and Hypertension Specialist, PLLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Renal Medicine Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
New York Hospital Queens
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Metrolina Nephrology Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Boice-Willis Clinic, PA
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Southeastern Dialysis Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Northeast Clinical Research Centers, Inc.
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Delaware Valley Nephrology and Hypertension Associates, PC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Palmetto Nephrology PA
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
SC Nephrology & Hypertension Center, Inc.
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Knoxville Kidney Center PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Research Management, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Gamma Clinical Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Nephrology, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Renal Associates, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215-2035
Country
United States
Facility Name
Southern Utah Kidney and Hypertension Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Mendez Center For Clinical Research, LLC
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
West Virginia University Hospitals and Clinic
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29084409
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.
Results Reference
derived

Learn more about this trial

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

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