CHOIR
Trial question
What is the role of epoetin alfa in patients with anemia of CKD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 1432
1432 patients (790 female, 642 male)
Inclusion criteria: patients with anemia of CKD
Key exclusion criteria: uncontrolled hypertension, active gastrointestinal bleeding, an iron-overload state, a history of frequent transfusions in the previous 6 months, refractory iron-deficiency anemia, active cancer, or previous therapy with epoetin alfa
Interventions
N=715 high-hemoglobin (administration of epoetin alfa for a target hemoglobin level of 13.5 g/dL)
N=717 low-hemoglobin (administration of epoetin alfa for a target hemoglobin level of 11.3 g/dL)
Primary outcome
Death, myocardial infarction, hospitalization for congestive heart failure, or stroke.
17.5
13.5
17.5 %
13.1 %
8.8 %
4.4 %
0.0 %
High-hemoglobin
Low-hemoglobin
Significant
increase ▲
NNH = 25
Significant increase in death, myocardial infarction, hospitalization for congestive HF, or stroke. (17.5% vs. 13.5%; HR 1.34, 95% CI 1.03 to 1.74)
Secondary outcomes
No significant difference in death (7.3% vs. 5%; HR 1.48, 95% CI 0.97 to 2.27)
No significant difference in hospitalization for congestive HF (9% vs. 6.6%; HR 1.41, 95% CI 0.97 to 2.05)
Significant increase in hospitalization for cardiovascular causes (32.6% vs. 27.5%; HR 1.23, 95% CI 1.01 to 1.48)
Safety outcomes
No significant difference in adverse event and thrombovascular event.
Significant difference in serious adverse event (54.8% vs. 48.5%) and congestive HF (11.2% vs. 7.4%).
Conclusion
In patients with anemia of CKD, high-hemoglobin was inferior to low-hemoglobin with respect to death, myocardial infarction, hospitalization for congestive HF, or stroke..
Reference
Singh AK, Szczech L, Tang KL et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98.
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