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Fixed Dose NESP Study in Subjects With CRI

This study has been completed.
Information provided by:
Amgen Identifier:
First received: September 6, 2007
Last updated: May 21, 2009
Last verified: May 2009
Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.

Condition Intervention Phase
Drug: darbepoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel Erythropoiesis Stimulating Protein (NESP) to Subjects With Chronic Renal Insufficiency (CRI)

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI [ Time Frame: entire study - 24 weeks ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of chronic NESP therapy [ Time Frame: entire study - 24 weeks ]

Estimated Enrollment: 75
Study Start Date: May 2000
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: darbepoetin alfa
darbepoetin alfa (NESP)
Drug: darbepoetin alfa
10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week


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

Inclusion Criteria:

  • Greater than or equal to 18 years of age
  • CRI with a creatinine clearance of less than 40 mL/min
  • Hemoglobin less than 11.0 g/dL
  • Serum vitamin B12 and folate levels above the lower limit of normal and iron replete

Exclusion Criteria:

  • Received rHuEPO therapy in the last 12 weeks
  • Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
  • Uncontrolled hypertension
  • Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding
  Contacts and Locations
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Please refer to this study by its identifier: NCT00526929

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00526929     History of Changes
Other Study ID Numbers: 990151
Study First Received: September 6, 2007
Last Updated: May 21, 2009

Additional relevant MeSH terms:
Darbepoetin alfa
Hematinics processed this record on April 26, 2017