Trial record 9 of 4616 for:    "Kidney Diseases"

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
  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:


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:
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 April 17, 2014