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Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00093977
Recruitment Status : Completed
First Posted : October 11, 2004
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Kidney Disease Chronic Kidney Disease Drug: darbepoetin alfa SF Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: darbepoetin alfa SF 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





Primary Outcome Measures :
  1. 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 Measures :
  1. To characterize laboratory parameters in subjects with CKD [ Time Frame: Entire Study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
  • Anemic
  • Currently on erythropoietic therapy
  • Controlled hypertension
  • Clinically stable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093977


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00093977     History of Changes
Other Study ID Numbers: 20040180
First Posted: October 11, 2004    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013

Keywords provided by Amgen:
Chronic Kidney Disease
Dialysis
Anemia
Nephrology

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics