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Previous Volume 355:2085-2098 November 16, 2006 Number 20 Next

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ABSTRACT

Background Anemia, a common complication of chronic kidney disease, usually develops as a consequence of erythropoietin deficiency. Recombinant human erythropoietin (epoetin alfa) is indicated for the correction of anemia associated with this condition. However, the optimal level of hemoglobin correction is not defined.

Methods In this open-label trial, we studied 1432 patients with chronic kidney disease, 715 of whom were randomly assigned to receive a dose of epoetin alfa targeted to achieve a hemoglobin level of 13.5 g per deciliter and 717 of whom were assigned to receive a dose targeted to achieve a level of 11.3 g per deciliter. The median study duration was 16 months. The primary end point was a composite of death, myocardial infarction, hospitalization for congestive heart failure (without renal replacement therapy), and stroke.

Results A total of 222 composite events occurred: 125 events in the high-hemoglobin group, as compared with 97 events in the low-hemoglobin group (hazard ratio, 1.34; 95% confidence interval, 1.03 to 1.74; P=0.03). There were 65 deaths (29.3%), 101 hospitalizations for congestive heart failure (45.5%), 25 myocardial infarctions (11.3%), and 23 strokes (10.4%). Seven patients (3.2%) were hospitalized for congestive heart failure and myocardial infarction combined, and one patient (0.5%) died after having a stroke. Improvements in the quality of life were similar in the two groups. More patients in the high-hemoglobin group had at least one serious adverse event.

Conclusions The use of a target hemoglobin level of 13.5 g per deciliter (as compared with 11.3 g per deciliter) was associated with increased risk and no incremental improvement in the quality of life. (ClinicalTrials.gov number, NCT00211120 [ClinicalTrials.gov] .)

Source Information

From the Renal Division, Brigham and Women's Hospital and Harvard Medical School, Boston (A.K.S.); the Renal Division, Duke University Medical Center (L.S., D.R.), Duke Clinical Research Institute (L.S., S.S.), and the Department of Biostatistics and Bioinformatics, Duke University (H.B.) — all in Durham, NC; Ortho Biotech Clinical Affairs, Bridgewater, NJ (K.L.T., M.W.); and the Department of Medicine, University College Galway, Galway, Ireland (D.R.).

Address reprint requests to Dr. Singh at the Renal Division, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at asingh{at}partners.org.

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