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Phase 2 Study of Darbepoetin Alfa Extended Dosing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527215
First Posted: September 10, 2007
Last Update Posted: May 22, 2009
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.
Information provided by:
Amgen
  Purpose
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.

Condition Intervention Phase
Pre-Dialysis Drug: darbepoetin alfa Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks [ Time Frame: Study weeks 21 - 29 ]

Secondary Outcome Measures:
  • To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks. [ Time Frame: Entire study ]

Enrollment: 98
Study Start Date: March 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: darbepoetin alfa Drug: darbepoetin alfa
starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL

  Eligibility

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
Criteria

Inclusion Criteria:

  • Greater than or equal to 18 years of age
  • CRI with a creatinine clearance of greater than 15 but less than 40 mL/min
  • Stable once every other week darbepoetin alfa SC for at least 6 weeks
  • Hb values during screening / baseline of 10.0 - 12.0 g/dL
  • Serum B12 and folate levels above the lower limit of normal and iron replete

Exclusion Criteria:

  • Receiving renal replacement therapy
  • Uncontrolled hypertension
  • Hyperparathyroidism
  • Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
  • Current malignancy
  • Pregnant or breast-feeding
  Contacts and Locations
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): NCT00527215


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

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00527215     History of Changes
Other Study ID Numbers: 20010212
First Submitted: September 6, 2007
First Posted: September 10, 2007
Last Update Posted: May 22, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Darbepoetin alfa
Hematinics