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NCT05768997Recruiting

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
Hallym University Medical CenterPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Anemia
Drug/Device/Intervention
Ferric Derisomaltose Injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Hallym University Medical Center
Location
Anyang-si, South Korea
Timeline & enrollment
Phase
Phase 3
Start date
Mar 01, 2023
End date
Dec 31, 2025
Enrollment
312 participants
Primary outcome

Mean Hb change

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.

ICD-10 classifications
Anaemia, unspecifiedOther anaemiasOther specified anaemiasIron deficiency anaemiaIron deficiency anaemia, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05768997
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05768997 through Pure Global AI's free database. This Phase 3 trial is sponsored by Hallym University Medical Center and is currently Recruiting. The study focuses on Anemia. Target enrollment is 312 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.