Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
Primary Purpose
Kidney Disease, Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
darbepoetin alfa SF
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Anemia, Nephrology
Eligibility Criteria
Inclusion Criteria: Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis Anemic Currently on erythropoietic therapy Controlled hypertension Clinically stable
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
darbepoetin alfa SF
Arm Description
Outcomes
Primary Outcome Measures
To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
Secondary Outcome Measures
To characterize laboratory parameters in subjects with CKD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00093977
Brief Title
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
Official Title
An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Dialysis, Anemia, Nephrology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
darbepoetin alfa SF
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa SF
Intervention Description
Frequency of dosing depends on frequency at randomization:
rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL
Primary Outcome Measure Information:
Title
To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
Time Frame
Entire Study
Secondary Outcome Measure Information:
Title
To characterize laboratory parameters in subjects with CKD
Time Frame
Entire Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
Anemic
Currently on erythropoietic therapy
Controlled hypertension
Clinically stable
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
19954265
Citation
Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741.
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_33_NESP_20040180.pdf
Description
To access clinical trial results information click on this link
URL
http://www.aranesp.com
Description
FDA-approved Drug Labeling
Learn more about this trial
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
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