drugset / Trial / NCT05768997

High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

NCT05768997

Phase 3 Unknown 312 enrolled Hallym University Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.

Timeline

Start
2023-03-01
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Darbepoetin alfa Protein / enzyme biologic 6.75 ug/kg Subcutaneous
Subject Ferric Derisomaltose Unknown 20 mg/kg Intravenous

Indications