drugset / Trial / NCT00925587

Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

NCT00925587

Phase 3 Completed 358 enrolled Amgen
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.

Timeline

Start
2009-06
Primary completion
2012-04
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darbepoetin alfa Protein / enzyme biologic 10 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 20 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 30 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 40 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 50 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 60 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 80 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 100 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 130 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 150 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 200 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 300 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 400 ug
Comparator Darbepoetin alfa Protein / enzyme biologic 600 ug