Back to resultsEfficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
Primary Purpose
Nephrology
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Epoetin alfa RB
Epoetin alfa DT
Sponsored by
About this trial
This is an interventional treatment trial for Nephrology focused on measuring anemia, chronic kidney disease, CKD, hemodialysis, epoetin, Epogen®
Eligibility Criteria
Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization Exclusion Criteria: - Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epoetin alfa RB
Epoetin alfa DT
Arm Description
Outcomes
Primary Outcome Measures
Ratio of weekly dose at the evaluation period to the weekly dose at baseline
Change in Heloglobin level between the screening period and the evaluation period
Secondary Outcome Measures
Change from baseline Hb at each measurement timepoint
Maintaining Hemoglobin within range at each measurement timepoint
Average Epoetin alfa dose over evaluation period
Change from baseline dose at each measurement timepoint
Epoetin alfa seroreactivity
Subject incidence, nature and severity of adverse events
Hemoglobin variability
changes from baseline laboraotry and vital sign parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00146224
Brief Title
Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
Official Title
A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Receiving Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrology
Keywords
anemia, chronic kidney disease, CKD, hemodialysis, epoetin, Epogen®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epoetin alfa RB
Arm Type
Active Comparator
Arm Title
Epoetin alfa DT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa RB
Intervention Description
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa DT
Intervention Description
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Primary Outcome Measure Information:
Title
Ratio of weekly dose at the evaluation period to the weekly dose at baseline
Time Frame
Entire Study
Title
Change in Heloglobin level between the screening period and the evaluation period
Time Frame
Entire Study
Secondary Outcome Measure Information:
Title
Change from baseline Hb at each measurement timepoint
Time Frame
Entire Study
Title
Maintaining Hemoglobin within range at each measurement timepoint
Time Frame
Entire Study
Title
Average Epoetin alfa dose over evaluation period
Time Frame
evaluation period (weeks 21 - 28)
Title
Change from baseline dose at each measurement timepoint
Time Frame
entire study
Title
Epoetin alfa seroreactivity
Time Frame
entire study
Title
Subject incidence, nature and severity of adverse events
Time Frame
entire study
Title
Hemoglobin variability
Time Frame
entire study
Title
changes from baseline laboraotry and vital sign parameters
Time Frame
entire study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization Exclusion Criteria: - Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20077249
Citation
Lei L, Olson K. Evaluating statistical methods to establish clinical similarity of two biologics. J Biopharm Stat. 2010 Jan;20(1):62-74. doi: 10.1080/10543400903115082.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_05_EPO_20050113.pdf
Description
To access clinical trial results information click on this link
URL
http://www.epogen.com/
Description
FDA-approved Drug Labeling
Learn more about this trial
Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
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