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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
History of Changes
  Purpose

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 Intervention Phase
Kidney Disease
Chronic Kidney Disease
 Drug: darbepoetin alfa SF
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

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 [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize laboratory parameters in subjects with CKD [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1100
Study Start Date: October 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093977

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00093977     History of Changes
Other Study ID Numbers: 20040180
Study First Received: October 7, 2004
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Chronic Kidney Disease
Dialysis
Anemia
Nephrology

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
 Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013