Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)
Completed
Amgen
Phase 3
2004-08-01
The purpose of this study is to assess the impact of treatment of anemia with darbepoetin
alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular
events, and (2) progression to end-stage renal disease or death, in subjects with chronic
kidney disease and type 2 diabetes mellitus.
Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD
Evaluating Aranesp® for the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis
Completed
Amgen
Phase 4
2002-05-01
This study is designed to evaluate the hemoglobin response to Aranesp® (darbepoetin alfa) in
black subjects (African-Americans) with chronic renal failure (CRF) receiving hemodialysis
and to examine the safety profile.
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
Completed
Amgen
Phase 3
2005-05-01
Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb)
≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV
darbepoetin alfa results in a mean Hb > 11 g/dL.
Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL
from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at >
11 g/dL.
A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia
Completed
Amgen
Phase 4
2004-01-01
The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg
every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and
maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network
(NCCN) guidelines).
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