Status:
COMPLETED
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
Lead Sponsor:
Amgen
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemi...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)
- Two consecutive screening Hb values taken at least 7 days apart must each be \<10.0 g/dL
- TSAT ≥ 15%
Exclusion
- Upper or lower GI bleeding within 6 months before enrolment
- ESA use within 12 weeks before enrolment
- Uncontrolled hypertension
- Systemic haematologic disorders
- Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism.
- Grand mal seizure within 6 months prior to enrolment
- Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment.
- Red blood cell transfusion within 12 weeks prior to enrolment
- Androgen therapy within 8 weeks prior to enrolment
- Pregnancy or breast feeding, or inadequate contraception
- Currently receiving immunosuppressive therapy
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00925587
Start Date
June 1 2009
End Date
May 1 2012
Last Update
June 4 2014
Active Locations (157)
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1
Research Site
Gosford, New South Wales, Australia, 2250
2
Research Site
Liverpool, New South Wales, Australia, 2170
3
Research Site
New Lambton, New South Wales, Australia, 2305
4
Research Site
Randwick, New South Wales, Australia, 2031