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 Center1 site in 1 country312 target enrollmentMarch 1, 2023

ConditionsAnemia

InterventionsFerric Derisomaltose Injection Darbepoetin Alfa Injection

DrugsFerric Derisomaltose Injection Darbepoetin Alfa Injection

Overview

Phase: Phase 3
Intervention: Ferric Derisomaltose Injection
Conditions: Anemia
Sponsor: Hallym University Medical Center
Enrollment: 312
Locations: 1
Primary Endpoint: Mean Hb change
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 1, 2023

End Date

December 31, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hallym University Medical Center

Responsible Party

Principal Investigator

Zang, Dae Young

Principal Investigator

Hallym University Medical Center

Eligibility Criteria

Inclusion Criteria

•Patient who has signed a written consent
•Age ≥ 19 ③ Histologically diagnosed advanced/metastatic solid cancer
•Patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study
•Anemia with functional iron deficiency
•Hemoglobin \<10g/dL
•functional iron deficiency: transferrin saturation \<50% AND serum ferritin 30-800ng/mL ⑤ ECOG performance status 0-2 ⑥ life expectancy ≥ 24weeks

Exclusion Criteria

•Absolute iron deficiency (serum ferritin \<30 ng/mL AND transferrin saturation \<20%) or no iron deficiency (serum ferritin ≥800 ng/mL OR transferrin saturation ≥50%)
•If there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin B12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.)
•Ongoing bleeding at the time of study registration
•Patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia)
•Presence of bone marrow tumor invasion
•Receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration
•History of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration
•Past or family history of hemochromatosis ⑨ History of hypersensitivity to iron treatment or erythropoiesis stimulating agents ⑩ Uncontrolled acute or chronic infection ⑪ Renal dysfunction (serum creatinine ≥2.0 mg/dL, or glomerular filtration rate \<30 mL/min/1.73 m2) or liver dysfuction (AST or ALT 3 times or more the upper limit of normal) ⑫ Pregnant or lactating women

Arms & Interventions

High dose IV iron plus ESA combination arm

Intervention: Ferric Derisomaltose Injection

High dose IV iron plus ESA combination arm

Intervention: Darbepoetin Alfa Injection

ESA monotherapy arm

Intervention: Darbepoetin Alfa Injection

Outcomes

Primary Outcomes

Mean Hb change

Time Frame: from baseline to 12 weeks

Mean change in Hb concentration from baseline to 12 weeks

Secondary Outcomes

Time to hemoglobin response(during 12-week study period)
Proportion of patients requiring RBC transfusion during 12-week study period(during 12-week study period)
Safety analysis(during 12-week study period)
Hemoglobin response(during 12-week study period)
Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L(during 12-week study period)