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Fixed Dose NESP Study in Subjects With CRI

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ClinicalTrials.gov Identifier: NCT00526929
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : May 22, 2009
Sponsor:
Information provided by:
Amgen

Brief Summary:
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 or disease Intervention/treatment Phase
Pre-Dialysis Drug: darbepoetin alfa Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : May 2000
Primary Completion Date : February 2002
Study Completion Date : February 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. To assess the safety and tolerability of chronic NESP therapy [ Time Frame: entire study - 24 weeks ]


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 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

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): NCT00526929


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00526929     History of Changes
Other Study ID Numbers: 990151
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: May 22, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Darbepoetin alfa
Hematinics