drugset / Trial / NCT00440063

A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

NCT00440063

Phase 4 Terminated Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Background epoetin alfa Protein / enzyme biologic

Indications