drugset / Trial / NCT00827021

The Clinical Evaluation of the Dose of Erythropoietins Trial

NCT00827021

Phase 3 Completed 656 enrolled Giovanni FM Strippoli, MD
RandomizedParallel-groupOpen-labelTreatment

Summary

Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the most used treatment option. The purpose of this study is 1. the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy 2. to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).

Timeline

Start
2009-07
Primary completion
2014-07
Completion
2014-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose. Unknown 4000 iu Intravenous
Comparator Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose. Unknown 18000 iu Intravenous
Comparator epoetin alfa Protein / enzyme biologic 4000 iu Intravenous
Comparator epoetin alfa Protein / enzyme biologic 18000 iu Intravenous