drugset / Trial / NCT00211120

Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

NCT00211120 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRIT® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.

Timeline

Start
2002-03
Primary completion
—
Completion
2005-08

Outcome

Missed primary endpoint

Stopped: “Stopped by the DSMB due to a trend toward more adverse events in the higher hemoglobin (Hb) arm and \<5% chance that the study would show benefit for higher Hb.”

paper 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). PMID 17108343 ↗

paper was associated with increased risk and no incremental improvement in the quality of life. PMID 17108343 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 10000 iu Subcutaneous

Indications