drugset / Trial / NCT00117624

A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy

NCT00117624 ↗

Phase 3 Completed Amgen
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.

Timeline

Start
2002-12
Primary completion
—
Completion
2003-12

Outcome

Met primary endpoint

paper The difference (95% CI) in transfusions was 0.4% (-7.0 to 7.8), demonstrating non-inferiority between treatment groups. PMID 17559735 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Darbepoetin alfa Protein / enzyme biologic 2.25 ug/kg —
Subject Darbepoetin alfa Protein / enzyme biologic 4.5 ug/kg —

Indications