Fixed Dose NESP Study in Subjects With CRI
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)
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2000
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedMay 22, 2009
May 1, 2009
1.8 years
September 6, 2007
May 21, 2009
Conditions
Outcome Measures
Primary Outcomes (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
entire study - 24 weeks
Secondary Outcomes (1)
To assess the safety and tolerability of chronic NESP therapy
entire study - 24 weeks
Study Arms (1)
darbepoetin alfa
EXPERIMENTALdarbepoetin alfa (NESP)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Suranyi MG, Lindberg JS, Navarro J, Elias C, Brenner RM, Walker R. Treatment of anemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease. Am J Nephrol. 2003 Mar-Apr;23(2):106-11. doi: 10.1159/000068041.
PMID: 12481149RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
May 1, 2000
Primary Completion
February 1, 2002
Study Completion
February 1, 2002
Last Updated
May 22, 2009
Record last verified: 2009-05