Phase 2 Study of Darbepoetin Alfa Extended Dosing

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00527215
First received: September 6, 2007
Last updated: May 21, 2009
Last verified: May 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 6, 2007
Last Updated: May 21, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014