TREAT
Trial question
What is the role of darbepoetin alfa in patients with T2DM and CKD and anemia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 4038
4038 patients (2312 female, 1726 male).
Inclusion criteria: patients with diabetes, CKD, and moderate anemia (hemoglobin level < 9.0 g/dL) who were not undergoing dialysis.
Key exclusion criteria: uncontrolled hypertension; previous kidney transplantation or scheduled receipt of a kidney transplant from a living related donor; current use of intravenous antibiotics, chemotherapy, or radiation therapy; diagnosed HIV infection; active bleeding; a hematologic disease; or pregnancy.
Interventions
N=2012 darbepoetin alfa (Aranesp, Amgen, to target hemoglobin level of approximately 13 g/dL).
N=2026 placebo (matching placebo).
Primary outcome
Death or a cardiovascular event
31.4%
29.7%
31.4 %
23.5 %
15.7 %
7.8 %
0.0 %
Darbepoetin
alfa
Placebo
No significant
difference ↔
No significant difference in death or a cardiovascular event (31.4% vs. 29.7%; HR 1.05, 95% CI 0.94 to 1.17).
Secondary outcomes
No significant difference in death or ESRD (32.4% vs. 30.5%; HR 1.06, 95% CI 0.95 to 1.19).
Significant increase in fatal or nonfatal stroke (5% vs. 2.6%; HR 1.92, 95% CI 1.38 to 2.68).
Significant decrease in cardiac revascularization (4.2% vs. 5.8%; HR 0.71, 95% CI 0.54 to 0.94).
Safety outcomes
Significant difference in change in patient-reported fatigue (54.7% vs. 49.5%,p = 0.002).
Conclusion
In patients with diabetes, CKD, and moderate anemia (hemoglobin level < 9.0 g/dL) who were not undergoing dialysis, darbepoetin alfa was not superior to placebo with respect to death or a cardiovascular event.
Reference
Pfeffer MA, Burdmann EA, Chen CY et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009 Nov 19;361(21):2019-32.
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