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A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115167
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : May 11, 2009
Information provided by:

Brief Summary:
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Condition or disease Intervention/treatment Phase
Anemia Cancer Drug: Placebo Drug: Darbepoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Study Start Date : August 2004
Primary Completion Date : January 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Darbepoetin alfa Drug: Darbepoetin alfa
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: throughout study ]

Secondary Outcome Measures :
  1. Confirmed antibody formation to investigational product [ Time Frame: throughout study ]
  2. Deaths on study [ Time Frame: on study ]
  3. Laboratory parameters [ Time Frame: throughout study ]
  4. Vital signs (blood pressure) [ Time Frame: throughout study ]
  5. Change in PRO scores [ Time Frame: from baseline to end of treatment ]

Information from the National Library of Medicine

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

Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

  • Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
  • Subjects who have other diagnoses not related to the cancer which can cause anemia
  • Known history of seizure disorder
  • Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
  • Subject of reproductive potential who is not using adequate contraceptive precautions
  • Concerns for subject's compliance with the protocol procedures

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 identifier (NCT number): NCT00115167

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00115167     History of Changes
Other Study ID Numbers: 20020149
First Posted: June 22, 2005    Key Record Dates
Last Update Posted: May 11, 2009
Last Verified: May 2009

Keywords provided by Amgen:
Cancer-related anemia

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa