At a glance
ClinicalIndex Comparison Record- ✓Hemoglobin ≤11 g/dL at baseline
- ✓History of Chronic Kidney Disease
- ✓eGFR between 20 and 60 mL/min/1.73 m²
- ✓Transferrin saturation >15%
- ✕Uncontrolled hypertension
- ✕Erythropoietic protein use within 12 weeks of randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trial to Reduce Cardiovascular Events With Aranesp® Therapy
In Brief
A Phase 3 clinical trial evaluating Placebo and darbepoetin alfa for Kidney Disease and 2 related conditions. Completed, enrolled 4,038 participants.
Detailed Summary
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
Study Details
Timeline
Interventions
Volume and dose frequency changes resembling dosing in the active treatment group
Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL