NCT05768997

High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Prospective, Multicenter, Randomized Phase 3 Trial of High Dose IV Iron in Combination of Erythrocytosis Stimulating Agents in Chemotherapy Induced Anemia With Functional Iron Deficiency

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Hallym University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Ferric Derisomaltose Injection	Ferric derisomaltose/iron isomaltoside (as iron) (0 weeks): 20mg/kg, diluted in 250ml of 0.9% physiological saline and injected intravenously over 30-60 minutes
DRUG	Darbepoetin Alfa Injection	Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-03-15
• Last updated: 2023-03-15

Locations

1 site across 1 country: South Korea