Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00093977
First received: October 7, 2004
Last updated: May 22, 2013
Last verified: May 2013

October 7, 2004
May 22, 2013
October 2004
January 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00093977 on ClinicalTrials.gov Archive Site
To characterize laboratory parameters in subjects with CKD [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
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Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Disease
  • Chronic Kidney Disease
Drug: darbepoetin alfa SF

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

Experimental: darbepoetin alfa SF
Intervention: Drug: darbepoetin alfa SF
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
  • Anemic
  • Currently on erythropoietic therapy
  • Controlled hypertension
  • Clinically stable
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00093977
20040180
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP